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EC number: 248-570-1 | CAS number: 27610-92-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In the oral study according to OECD 422 with the Source Substance 2, docosanoic acid, no developmental no reproductive effects were observed. The NOAEL of the study was 1000 mg/kg bw/d, means the highest dose tested did not cause adverse effects.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- The functional group of the source substance docosanoic acid and the target substance is similar. Both substances are long chain acids which have no other funcitional group. Based on the similar structure and therefore similar expected toxicokinetic it is likely that the test result of this substance is also valid for the Category member (Please see attached Category Approach.)
- Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse substance -related findings on fertility were noted
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Sexual maturation:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Developmental immunotoxicity:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects observed
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Key result
- Reproductive effects observed:
- not specified
Reference
- Males: no deaths or abnormalities in general condition were observed in any of the treated groups
- Females: no deaths were observed in any treated group
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)
Males: significant increase (p<0.01) compared to control was observed in 100 mg/kg group between 8 - 15 days and between 15 - 29 days. However, since no change was observed in other groups, the effect was not considered to be related to the dosing of compound. No changes in food consumption related to the dosing of compound were observed
- Females: no significant changes in body weight were noted and there were no changes related to the dosing of compound in body weight gain and food consumption. A significant decrease (p<0.01) compared to control was observed during lactation in 100 mg/kg dosing group. However, since no other changes in food consumption were noted in 300 mg/kg and 1000 mg/kg dosing groups, the effect was not considered to be related to the dosing of compound.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
There were no significant differences in number of corpora lutea, implantation rate, number of implantations and all other reproductive parameters in all treated groups compared to the control group.
ORGAN WEIGHTS (PARENTAL ANIMALS)
Males: in 100 mg/kg bw males, the actual weight ratio of liver weight (p <0.05) compared to control values were increased. No other significant differences were found in all groups. Thus, this finding lacks a dose-dependency and was regarded as incidental.
- Females: kidney weight was significantly reduced (p<0.05) in the 300 mg/kg bw group. No other weight changes were noted. Thus, this finding lacks a dose-dependency and was regarded as incidental.
GROSS PATHOLOGY (PARENTAL ANIMALS)
Males:
- Heart: myocardial degeneration was noted in one animal of the control group and the 1000 mg/kg bw group, respectively
- Liver: periportal fatty change of the liver was found in all animals of the control and the high dose group. Focal necrosis was noted in one animal of the high-dose group.
- Spleen: all animals of the control and the high-dose group showed brown pigment deposits of the spleen as well as extramedullary haematopeiosis
- Kidney: while fibrosis was only found in 1/13 animals of the control group, eosinophilic bodies and basophilic tubuli in the cortex were noted in animals of both control and high dose groups, respectively
- Adrenal gland: one animal of the high-dose group showed fibrosis
- Testis: atrophy of the seminiferous tubules was observed in two animals of the 1000 mg/kg dose group, with one animal affected on both sides and one side affected in the other animal. No other abnormalities were noted.
- Epididymis: abnormal sperm granuloma was found in one animal of the control group
- Brain: no abnormal findings noted
- Thymus: no abnormal findings noted
- Bladder: no abnormal findings noted
Females:
- Brain: one animal of the high-dose group showed abnormal mineral deposition in the thalamus
- Liver: focal necrosis and fibrosis was found in one animal of the control group, while one animal of the high-dose group showed only focal necrosis
- Spleen: brown pigmentation and extramedullary haematopeiosis was found in animals of the control and the high-dose group, but no varying degrees of frequency was observed
- Thymus: atrophy and bleeding was observed in animals of both groups, control and high-dose group, respectively
- Kidney: basophilic tubuli of the cotex and a dilatation of the renal pelvis was seen in the control and high-dose group
- Adrenal gland: cortical necrosis was observed in one animal of the control group
- Heart: no abnormal findings noted
- Bladder: no abnormal findings noted
No change in number of birth, birth rate, infant live birth rate, infant survival and birth rates at day 4 was found in all dose groups compared to the values of the control group.
BODY WEIGHT (OFFSPRING)
No difference in bodyweight of pups of the dose groups and the control group was found.
GROSS PATHOLOGY (OFFSPRING)
No morphological abnormalities were found in all groups.
Table 1. Summary of development up of pups from dams treated orally with docosanoic acid in the combined repeat dose and reproductive/developmental toxicity screening test: Mean± S.D (N)
Dose group (mg/kg) |
0 |
100 |
300 |
1000 |
Number of pregnant females |
13 |
12 |
12 |
13 |
Number of pregnant females with live pups |
13 |
12 |
12 |
13 |
Gestation index |
100 |
100 |
100 |
100 |
Gestation length in days |
22.2±0.4 (13) |
22.4±0.5 (12) |
22.3±0.5 (12) |
22.2±0.4 (13) |
Number of corpora lutea |
16.6±1.6 (13) |
16.7±1.8 (12) |
16.8±2.3 (12) |
16.2±1.5 (13) |
Number of implantation sites |
16.1±1.5 (13) |
15.8±2.1 (12) |
16.0±1.5 (12) |
15.2±3.1 (13) |
Implantation index |
96.9±5.1 (13) |
94.8±7.1 (12) |
96.1±6.0 (12) |
93.1±15.2 (13) |
Day 0 of lactation |
|
|
|
|
Number of pups born |
15.2±1.6 (13) |
14.8±2.2 (12) |
15.2±1.5 (12) |
14.3±2.7 (13) |
Delivery index |
94.5±8.0 (13) |
93.5±3.9 (12) |
94.9±4.3 (12) |
94.9±6.2 (13) |
Number of live pups |
14.9±1.6 (13) |
14.3±2.2 (12) |
15.1±1.6 (12) |
14.1±2.7 (13) |
Birth index |
93.1±8.8 (13) |
90.7±8.7 (12) |
94.3±5.1 (12) |
93.5±7.2 (13) |
Live birth index |
98.5±2.8 (13) |
97.0±8.5 (12) |
99.4±2.2 (12) |
98.5±4.0 (13) |
Sex ration on day 0 |
50.0±11.3 (13) |
46.7±9.8 (12) |
54.8±12.3 (12) |
48.9±13.4(13) |
Day 4 of lactation |
|
|
|
|
Number of live pups |
14.7±1.4 (13) |
13.0±4.7 (12) |
15.1±1.6 (12) |
14.1±2.7 (13) |
Viability index |
98.6±2.7 (13) |
89.4±28.8 (12) |
100.0±0.0 (12) |
100.0±0.0 (13) |
Sex ration on day 4 |
49.8±11.5 (13) |
46.3±10.3 (11) |
54.8±12.3 (12) |
48.9±13.4(13) |
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klimisch 2
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
The target substance and Category member 2, 2 -butyl octanoic acid, was investigated for developmental toxicity testing in rats. Mated female Sprague-Dawley rats were randomised into 4 treatment groups, each containing 25 animals. These animals were dosed orally by gavage once daily over Days 6-19 inclusive of gestation, where Day 0 was the day of detection of mating. The dose levels applied were 0 (control); 25; 200 and 400 mg/kg bw/d. In conclusion, under the conditions of this study, the maternal No Effect Level was considered to be 25 mg/kg bw/d and the foetal No Effect Level was considered to be 200 mg/kg bw/d. In not maternal toxic dosages no teratogenic effects were found. Therefore the substance is considered to be not developmental toxic. In the oral study according to OECD 422 with the Source Substance 2, docosanoic acid, no developmental no reproductive effects were observed. The NOAEL of the study was 1000 mg/kg bw/d, means the highest dose tested did not cause adverse effects.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Klmisch 2
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
Based on the available data the target substance and Category Member 2 does not need to be classified.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
