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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity to reproduction

The reproductive toxicity of pentyl 2-phenylacetate (5137 -52 -0)was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor andNOAEL was estimated to be 902.59 mg/kg bw. When male and female wistarratswere exposed with pentyl 2-phenylacetate (5137 -52 -0) orally.

 Thus, based on the above studies and predictions onpentyl 2-phenylacetate (5137 -52 -0)and its read across substances, Adverse Effect Level (NOAEL) was considered to be 902.59mg/kg bw. Thus, comparing this value with the criteria of CLP regulationpentyl 2-phenylacetate (5137 -52 -0)cannot be classified as reproductive toxicant.

 

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:
Data is from OECD QSAR toolbox v3.3 and the QMRF report has been attached.
Qualifier:
equivalent or similar to guideline
Guideline:
other: As mentioned below
Principles of method if other than guideline:
Prediction was done using OECD QSAR toolbox v3.3, 2018
GLP compliance:
not specified
Limit test:
no
Specific details on test material used for the study:
- Name of the test material: pentyl 2-phenylacetate
- IUPAC name: pentyl 2-phenylacetate
- Molecular formula: C13H18O2
- Molecular weight: 206.283 g/mol
- Substance type: Organic
- Smiles: C(=O)(Cc1ccccc1)OCCCCC
- Physical State: Liquid
Species:
rat
Strain:
Wistar
Details on species / strain selection:
not specified
Sex:
male/female
Details on test animals or test system and environmental conditions:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
Details on exposure:
No data available
Details on mating procedure:
No data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
46 days
Frequency of treatment:
Daily
Details on study schedule:
No data available
Dose / conc.:
902.59 mg/kg bw/day (nominal)
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Positive control:
No data available
Parental animals: Observations and examinations:
No data available
Oestrous cyclicity (parental animals):
No data available
Sperm parameters (parental animals):
No data available
Litter observations:
No data available
Postmortem examinations (parental animals):
No data available
Postmortem examinations (offspring):
No data available
Statistics:
No data available
Reproductive indices:
No data available
Offspring viability indices:
No data available
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
no effects observed
Dose descriptor:
NOAEL
Effect level:
902.59 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
reproductive performance
Remarks on result:
other: No effects on reproductive performance
Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified
Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified
Behaviour (functional findings):
not specified
Developmental immunotoxicity:
not specified
Dose descriptor:
other: not specified
Generation:
other: not specified
Based on:
not specified
Sex:
not specified
Basis for effect level:
other: not specified
Remarks on result:
not measured/tested
Critical effects observed:
not specified
System:
other: not specified
Organ:
not specified
Treatment related:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified
Reproductive effects observed:
not specified
Treatment related:
not specified
Relation to other toxic effects:
not specified
Dose response relationship:
not specified
Relevant for humans:
not specified

The prediction was based on dataset comprised from the following descriptors: NOAEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

((((((((((((("a" or "b" or "c" or "d" )  and ("e" and ( not "f") )  )  and ("g" and ( not "h") )  )  and ("i" and ( not "j") )  )  and "k" )  and "l" )  and "m" )  and "n" )  and ("o" and ( not "p") )  )  and ("q" and ( not "r") )  )  and ("s" and ( not "t") )  )  and "u" )  and ("v" and "w" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Esters (Acute toxicity) by US-EPA New Chemical Categories

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Michael addition AND Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals AND Michael addition >> P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Arenes by DNA binding by OECD

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Esters by Acute aquatic toxicity MOA by OASIS

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Esters by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as No alert found by DNA binding by OASIS v.1.3

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as AN2 OR AN2 >> Michael-type addition on alpha, beta-unsaturated carbonyl compounds OR AN2 >> Michael-type addition on alpha, beta-unsaturated carbonyl compounds >> Four- and Five-Membered Lactones OR AN2 >> Schiff base formation by aldehyde formed after metabolic activation OR AN2 >> Schiff base formation by aldehyde formed after metabolic activation >> Geminal Polyhaloalkane Derivatives OR AN2 >> Shiff base formation after aldehyde release OR AN2 >> Shiff base formation after aldehyde release >> Specific Acetate Esters OR AN2 >> Shiff base formation for aldehydes OR AN2 >> Shiff base formation for aldehydes >> Geminal Polyhaloalkane Derivatives OR Non-covalent interaction OR Non-covalent interaction >> DNA intercalation OR Non-covalent interaction >> DNA intercalation >> Coumarins OR Radical OR Radical >> Generation of ROS by glutathione depletion (indirect) OR Radical >> Generation of ROS by glutathione depletion (indirect) >> Haloalkanes Containing Heteroatom OR Radical >> Radical mechanism via ROS formation (indirect) OR Radical >> Radical mechanism via ROS formation (indirect) >> Coumarins OR Radical >> Radical mechanism via ROS formation (indirect) >> Geminal Polyhaloalkane Derivatives OR SN1 OR SN1 >> Nucleophilic attack after carbenium ion formation OR SN1 >> Nucleophilic attack after carbenium ion formation >> Specific Acetate Esters OR SN2 OR SN2 >> Acylation OR SN2 >> Acylation >> Specific Acetate Esters OR SN2 >> Acylation involving a leaving group  OR SN2 >> Acylation involving a leaving group  >> Geminal Polyhaloalkane Derivatives OR SN2 >> Acylation involving a leaving group after metabolic activation OR SN2 >> Acylation involving a leaving group after metabolic activation >> Geminal Polyhaloalkane Derivatives OR SN2 >> Alkylation, direct acting epoxides and related OR SN2 >> Alkylation, direct acting epoxides and related >> Epoxides and Aziridines OR SN2 >> Alkylation, ring opening SN2 reaction OR SN2 >> Alkylation, ring opening SN2 reaction >> Four- and Five-Membered Lactones OR SN2 >> Direct acting epoxides formed after metabolic activation OR SN2 >> Direct acting epoxides formed after metabolic activation >> Coumarins OR SN2 >> DNA alkylation OR SN2 >> DNA alkylation >> Alkylphosphates, Alkylthiophosphates and Alkylphosphonates OR SN2 >> Nucleophilic substitution at sp3 Carbon atom OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Haloalkanes Containing Heteroatom OR SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Specific Acetate Esters OR SN2 >> Nucleophilic substitution at sp3 carbon atom after thiol (glutathione) conjugation OR SN2 >> Nucleophilic substitution at sp3 carbon atom after thiol (glutathione) conjugation >> Geminal Polyhaloalkane Derivatives by DNA binding by OASIS v.1.3

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OASIS v1.3

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Acyl transfer via nucleophilic addition reaction OR Acylation >> Acyl transfer via nucleophilic addition reaction >> Isocyanates, Isothiocyanates  OR Acylation >> Direct acylation involving a leaving group OR Acylation >> Direct acylation involving a leaving group >> Anhydrides (sulphur analogues of anhydrides)  OR Michael Addition OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group OR Michael Addition >> Michael addition on conjugated systems with electron withdrawing group >> alpha,beta-Carbonyl compounds with polarized double bonds  OR Schiff base formation OR Schiff base formation >> Schiff base formation with carbonyl compounds OR Schiff base formation >> Schiff base formation with carbonyl compounds >> Aldehydes OR SN2 OR SN2 >> SN2 Reaction at a sp3 carbon atom OR SN2 >> SN2 Reaction at a sp3 carbon atom >> Activated alkyl esters and thioesters  by Protein binding by OASIS v1.3

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Acylation OR Acylation >> Direct Acylation Involving a Leaving group OR Acylation >> Direct Acylation Involving a Leaving group >> Acetates OR SN2 OR SN2 >> SN2 reaction at sp3 carbon atom OR SN2 >> SN2 reaction at sp3 carbon atom >> Allyl acetates and related chemicals by Protein binding by OECD

Domain logical expression index: "k"

Referential boundary: The target chemical should be classified as Esters by Acute aquatic toxicity MOA by OASIS ONLY

Domain logical expression index: "l"

Referential boundary: The target chemical should be classified as Esters by Acute aquatic toxicity MOA by OASIS ONLY

Domain logical expression index: "m"

Referential boundary: The target chemical should be classified as Esters by Acute aquatic toxicity MOA by OASIS ONLY

Domain logical expression index: "n"

Referential boundary: The target chemical should be classified as Esters by Acute aquatic toxicity MOA by OASIS ONLY

Domain logical expression index: "o"

Referential boundary: The target chemical should be classified as Esters by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "p"

Referential boundary: The target chemical should be classified as Melamines by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "q"

Referential boundary: The target chemical should be classified as Group 14 - Carbon C AND Group 16 - Oxygen O by Chemical elements

Domain logical expression index: "r"

Referential boundary: The target chemical should be classified as Group 17 - Halogens Cl OR Group 17 - Halogens F,Cl,Br,I,At by Chemical elements

Domain logical expression index: "s"

Referential boundary: The target chemical should be classified as Not categorized by Repeated dose (HESS)

Domain logical expression index: "t"

Referential boundary: The target chemical should be classified as Phthalate esters (Testicular toxicity) Rank C by Repeated dose (HESS)

Domain logical expression index: "u"

Similarity boundary:Target: CCCCCOC(=O)Cc1ccccc1
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "v"

Parametric boundary:The target chemical should have a value of log Kow which is >= 2.1

Domain logical expression index: "w"

Parametric boundary:The target chemical should have a value of log Kow which is <= 8.13

Conclusions:
In reproductive toxicity study, NOAEL was estimated to be 902.59 mg/kg bw. When male and female wistar rats were exposed with pentyl 2-phenylacetate (5137-52-0) orally.
Executive summary:

The reproductive toxicity of pentyl 2-phenylacetate (5137-74-5)was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor and NOAEL was estimated to be 902.59 mg/kg bw. When male and female wistar rats were exposed with pentyl 2-phenylacetate (5137-52-0) orally.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
902.59 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Data is Klimicsh 2 and from QSAR Toolbox 3.3. (2018)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

Reproductive toxicity

In different studies pentyl 2-phenylacetate (5137 -52-0)has been investigated for reproductive toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for pentyl 2-phenylacetate (5137 -52-0).The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies performed on structurally similar read across substance.

The reproductive toxicity of pentyl 2-phenylacetate (5137 -52 -0) was estimated by SSS (2017) using OECD QSAR toolbox v3.3 with log kow as the primary descriptor andNOAEL was estimated to be 902.59 mg/kg bw. When male and female wistarratswere exposed with pentyl 2-phenylacetate (5137-52-0 orally.

It is supported by experimental study conducted by Sustainability Support Services (Europe) AB (reort no. 17871 and company study no SPL/122/004,2014) on structurally similar read across substance Benzyl Propionate(122-63-4).The reproductive toxicity of Benzyl Propionate(122-63-4) was considered on the bases of repeated dose 28-day Oral Toxicity study performed in GLP compliance lab. The male and female Sprague-Dawley rats were administered with test material in dose concentration 0 mg/kg, 250 mg/kg, 500 mg/kg and 1000 mg/kg bw/day by oral gavage route. Corn oil used as vehicle. Analysis for concentration and stability of Benzyl Propionate were conducted at Subcontracted Laboratory. The animals of uniform body weight were selected. The individual body weight of the animals did not exceed ± 20% of group mean body weight. The group means body weights of all the groups were approximately equal. A total of 48 animals (24 males + 24 females) were selected and randomly distributed into four groups with 6 animals/sex/group and 3/sex/cage. The doses were selected based on the results of the Dose Range Finder study, Based on these results, the 28 day study dose levels were finalized as 0 mg/kg,250 mg/kg, 500 mg/kg and 1000 mg/kg body weight and animals were exposed to the treatment, every day, for a period of 28 days. The test and/or control item was administered by oral gavage route, using a 18 gauge ball–tipped intubation needle fitted onto a gauge syringe of appropriate size. Doses were calculated using recent body weights, 10 ml per kg body weight is considered the volume which could be administered to a rat.

All the animals were observed for viability twice daily. Body weight was recorded on the day of randomization, first day of dosing, weekly thereafter and a fasting body weight at scheduled sacrifice on day 29.The quantity of feed consumed by control and different treatment groups was recorded weekly until scheduled sacrifice and the feed consumption per animal was calculated for each group. All animals were examined for clinical signs such as skin and fur changes, eye and mucous membrane changes, respiratory, circulatory and general changes were recorded once daily. In home cage, rats were observed for Behaviour, Alterations, Vocalizations, Respiration and Palpebral closure. After completion of 28 days study period, all surviving study rats were sacrificed on day 29.Liver, Kidneys, Adrenals, Epididymides, Prostate + Seminal Vesicle with Coagulation gland as whole, Thymus, Spleen, Brain, Heart, Lungs, Uterus, Testes/Ovaries were dissected free of fat and weighed. The paired organs were weighed together. All the rats survived through the dosing period of 28 days and were sacrificed and gross lesions were noted. From each rat, samples or the whole of the tissue were preserved. All tissues were fixed in 10% neutral buffered formalin except, eyes and testes of all animals were preserved in Davidson’s solution for 24 hours and transferred to 10% neutral buffered formalin. Following tissue samples of organs from control and animals treated at different dose groups were preserved and those from control and treated at the highest dose level of 1000 mg/kg were subjected to histopathological examination. Adrenals, Aorta, Brain (cerebrum, cerebellum and pons), Caecum, Cervix, Colon, Duodenum, Epididymides, Eyes, Heart, Ileum, Jejunum, Kidneys, Liver, Lungs, Mesenteric Lymphnodes, Oesophagus, Ovaries, Pancreas, Pituitary gland, Pharyngeal Lymphnodes, Prostate, Rectum, Skeletal Muscles, Skin with Mammary Gland, Spleen, Sternum with bone marrow, Sciatic Nerve, Spinal Cord (Cervical, mid thoracic and lumbar), Stomach, Seminal Vesicles with Coagulation Gland, Testes, Thymus, Thyroid, Trachea, Vagina, Urinary Bladder, Uterus. 

All the animals from control and all the treated dose groups survived throughout the dosing period of 28 days. Animals from control and different dose groups exhibited normal body weight gain and normal feed consumption throughout the dosing period of 28 days. No clinical signs of toxicity were observed in the animals throughout the dosing period of 28 days. Home cage observations in rats from all treated groups and control group revealed normal behaviour, alterations, vocalization, respiration and palpebral closure. 

During handling observation, handling of rats did not reveal any abnormality from all treated groups and control group. Open field observation of rats did not reveal any abnormality from all treated groups and control group. All animals from control and different dose groups showed normal arousal level, visual response, touch response, auditory response, tail pinch response and visual placing response. Normal air righting reflex was observed in all animals from control and different dose groups in week 4.

Grip strength values observed in male and female animals for control and different dose groups were comparable. Higher values for motor activity were observed in male animals from 500 mg/kg dose group for first interval (p≤0.05). Lower values were observed in female animals from 500 mg/kg dose group for first interval (p≤0.01) and for second interval (p≤0.05). These changes were within laboratory range and were considered to be of no toxicological importance.

In comparison with controls organ weight data of female animals sacrificed on day 29, revealed increased relative weight of liver (p≤0.05), ovaries (p≤0.01) and lungs (p≤0.05) of animals from 1000 mg/kg dose group.

Although significant changes in organ weights were observed in female animals from high dose group, no related gross pathological or histological changes were seen and hence considered to be of no toxicological importance. Gross pathological examination in male and female animals from control and different treatment groups did not reveal any abnormality.

Haematological analysis performed on 29thday revealed statistically significant increase in the values of Hb of male rats dosed at 500 mg/kg and 1000 mg/kg, MCHC of male rats dosed at 500 mg/kg, Total WBC of male rats dosed at 1000 mg/kg and Plateles of female rats dosed at 1000 mg/kg. The increase in the values of different parameters was marginal and within the normal laboratory limits. Clinical biochemistry analysis results, when compared between the test and control groups revealed below observations.

Statistically significant increase of Sodium in male rats dosed at 250 mg/kg and 1000 mg/kg of test item.

·        Statistically significant increase of Chloride levels in male rats dosed at 250 mg/kg of test item.

·        Statistically significant increase of Calcium levels in female rats dosed at 250 mg/kg of test item.

·        Statistically significant increase of Bilirubin levels in female rats dosed at 500 mg/kg of test item.

·        Statistically significant increase of Sodium in female rats dosed at 250 mg/kg, 500 mg/kg and 1000 mg/kg of test item.

·        Statistically significant decrease of Alkaline Phosphatase levels in female rats dosed at 250 mg/kg of test item.

·        Statistically significant decrease of Potassium levels in female rats dosed at 250 mg/kg and 1000 mg/kg of test item.

·        Statistically significant decrease of Chloride levels in female rats dosed at 1000 mg/kg of test item.

Although there was an increase/decrease in the values of various biochemical parameters as mentioned above, the deviations were marginal and within the range of normal laboratory limits.

No treatment related histopathological changes were evident in male and female rats from control and high dose groups. Histopathological examination revealed minimal focal to multifocal periportal mononuclear cell infiltration in the liver; minimal interstitial haemorrhages in the kidneys; minimal alveolar haemorrhages and/or alveolar histiocytosis in the lungs; minimal multifocal haemosiderosis and/or diffused congestion in spleen; minimal eosinophilic infiltration and/or luminal dilatation in uterus; minimal luminal seminal coagulum in the urinary bladder; minimal dilatation of zona reticularis and/or presence of accessory adrenocortical tissue in adrenals; minimal multifocal haemorrhages in thymus; presence of ultimobranchial cysts in thyroid; in male or female animals from control and high dose group. All the changes observed in the control and high dose treatment group animals were similar, incidental and mode of death related, physiological and are covered in the facility historical data of the histopathology findings. Hence No Observed Adverse Effect Level (NOAEL) was considered to be 1000mg/kg bw on the bases of no effects on reproductive organ .when male and female Sprague-Dawley rats were treated with Benzyl Propionate(122-63-4) orally for 28 days.

It is further supported by experimental study conducted by NATIONAL TOXICOLOGY PROGRAM (NATIONAL TOXICOLOGY PROGRAM Technical Report Series No. 431, 1993)on structurally similar read across substance Benzyl acetate(140-11-4).The reproductive toxicity study of Benzyl acetate(140-11-4) was performed on male and female F344/N Rates by repeated oral exposure for 13 weeks. The test material mix with feed and store for maximum 120 days after milling. All the animals provide with feed containing test material in dose concentration 0, 3130, 6250, 12500, 25000 or 50000ppm (0,230, 460, 900, 1750, or 3900 mg/kg for male rats and 0, 240, 480, 930, 1870, or 4500 mg/kg for female rats ) daily for 13 weeks. Each dose group contain 10 male and 10 female. Animals were grouped by weight and assigned to cages and the cages assigned to exposure groups using tables of random numbers. Feed and water were available ad libitum. Feed consumption was, recorded daily by cage. Rats were housed five per cage and mice were housed individually. Clinical findings were recorded once weekly. The animals were weighed at the beginning of the studies, weekly, and at the end of the studies. The animals were sacrifice by carbon dioxide asphyxiation or carbon dioxide anaesthesia followed by perfusion. Necropsy was performed on all animals at age of 19 weeks; Organs weighed were brain, right kidney, liver, pancreas, prostate gland, seminal vesicle, spleen, right testis, thymus, and uterus. Complete histopathologic examinations were performedon all control,25000 and 50,000ppm rats, and on all control. In addition togrosslesions, tissue masses, and associated lymph nodes, the tissues examined included: adrenal gland, bone (including marrow), brain, esophagus, gallbladder(mice), heart, kidney, large intestine (cecum, colon, and rectum), liver, lung, mammary gland, nose, ovary, pancreas, parathyroid gland, pituitary gland, preputialorclitoral gland , prostate gland, salivary gland, skin, small intestine, spleen, stomach (forestomach and glandular), testis with epididymis and seminal vesicle, thigh muscle, thymus, thyroid gland, tongue, trachea, urinary bladder, and uterus. The testis with epididymisof6,250 and 12,500ppm male rats were also examined.Bloodwas collected from the orbital sinus (rats)orheart (mice). Pancreas samples from all control and exposed male and female rats except the50,000ppm group and all control and exposed mice were collected. Liver samples from control,25,000and50,000ppm female rats were collected.H-haematocrit, haemoglobin, erythrocytes, mean erythrocyte volume, mean erythrocyte haemoglobin, mean erythrocyte haemoglobin concentration, platelets, reticulocytes, and leukocyte count and differential leukocyte count, cholesterol and triglyceride lipase, carboxypeptidase, chymotrypsin, and ribonuclease were observed.

 Clinical findings related to toxicity observed in the50,000 ppm rats included tremors, ataxia, and urine stains. These findings were first observed on day 15 of the study in nine males and six females and continued until the end of the study. Nine male and nine female rats in dose group 50,000ppm died or were killed moribund between weeks 2 and 8 , one female in dose group 12,500 ppm died under anaesthesia during blood collection at the end of study. The mean body weight gain and the final mean body weight of 25000ppm male rats were significantly lower than those of the control. The final mean body weight of 25000ppm male was 10% lower than that of the control group, whereas the final body weights of surviving 50000ppm male and female were less than half those of the control. Final mean body weights of male and female of other exposed group were similar to or slightly lower than those of the control. Feed consumption by exposed rats was similar to control in all group expect 25000ppm and 50,000ppm male and 50000ppm female. The reduced feed consumption by 25,000 and50,000 ppm males and50000ppm females may have been due to decreased palatability and/or toxicity. Slight differences in organ weights were observed and were considered secondary to the reduced body weights .Excluding the data from the50,000ppm males and females (only one survivor in each group), Haematology values for all exposed groups was similar to those of the control groups. The clinical chemistry evaluations showed significantly lower cholesterol levels in 12,500 and 25,000 ppm female rats than in the controls. No chemical-related differences occurred in the cholesterol or triglyceride levels in exposed males.

 Testicular changes related to chemical exposure occurred in male rats receiving 12,500, 25,000, and 50000ppm dosed feed. The lesions were characterized by mild or moderate aspermatogenesis in two50,000ppm male rats and atrophy of seminiferous tubules intwo25,000 ppm and one 12,500 ppm rats. In one25,000ppm rat, the seminiferous tubule atrophy was marked in severity and included atypical cells (enlarged, degenerated spermatozoa) in the corresponding epididymis and mild interstitial cell hyperplasia. The seminiferous tubule atrophy was minimal in severity in one 12,500 ppm rat. No testicular lesions occurred in the6,250ppm or lower exposure levels. Several changes in50,000ppm rats were considered indirectly related to chemical exposure. These changes included depletion of the cellular components of the bone marrow, thymus (atrophy), and splenic lymphoid follicles, zymogengranule depletion and increased basophilia of the pancreatic acinar cells (Cytoplasmic alteration), minimal to mild erosions of the glandular stomach, secretory depletion of the seminal vesicles, and immature hypoplastic uterus. These changes are frequently observed in rodents and are usually caused by debilitation, stress, age, or poor nutrition. Hence No Observed Adverse Effect Level (NOAEL) was considered to be 25000ppm i.e 1750mg/kg bw/day in male and1870mg/kg bw/day in female on the as no effects on reproductive organ .when male and female F344/N Rats were treated with Benzyl acetate(140-11-4)by repeated oral exposure for 13 weeks

 Thus, based on the above studies and predictions onpentyl 2-phenylacetate (5137 -52 -0)and its read across substances, Adverse Effect Level (NOAEL) was considered to be 902.59mg/kg bw. Thus, comparing this value with the criteria of CLP regulationpentyl 2-phenylacetate (5137-52-0)cannot be classified as reproductive toxicant.

 

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Thus, comparing this value with the criteria of CLP regulation pentyl 2-phenylacetate (5137 -52 -0)cannot be classified as reproductive toxicant.

 

Additional information