[No public or meaningful name is available]

Endpoint summary

Description of key information

Oral (OECD 423), rat (m/f) LD50 > 2000 mg/kg bw

Read-across from structural analogue source substance glycerides, C8-18 and C18-unsatd. mono- and di-,acetates (CAS 91052-13-0)

 

Dermal (OECD 402), rat (m/f) LD50 > 2000 mg/kg bw

Read-across from structural analogue source substance glycerides, C8-18 and C18-unsatd. mono- and di-,acetates (CAS 91052-13-0)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to the analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source CAS 91052-13-0

In addition to the key study with source substance CAS 91052 -13 -0, acute oral toxicity data is also available for source substance CAS 91744 -23 -9. For the latter source substance a LD50 value of > 2000 mg/kg bw was derived for male and female rats. Based on the study period the more recent study with CAS 91052 -13 -0 was selected as key study.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

As detailed in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in acute toxicity potential. The oral LD50 value for both source substances CAS 91052-13-0 and CAS 91744-23-9 is > 2000 mg/kg bw. Therefore the target substance is also expected to have a very low level of acute oral toxicity.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Dec 2009 - 05 Jan 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP-Guideline study, tested with the source substance glycerides, C8-18 and C18-unsatd. mono- and di-, acetates (CAS 91052-13-0). According to the ECHA guidance document ‘Practical guide 6: How to report read-across and categories' (ECHA, 2012), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: young adult animals (approx. 9-10 weeks old)
- Weight at study initiation: 160-190 g, body weight variation did not exceed ± 20% of the sex mean
- Fasting period before study: animals were deprived of food overnight prior to dosing and until 3-4 h after administration of the test substance, water was available
- Housing: group housing of 3 animals per cage in labeled Macrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, UK).
- Diet: pelleted rodent diet (SM R/M-Z from SSNlFF® Spezialdiaten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3 (actual range: 18.4- 21.8)
- Humidity (%): 40-70 (actual range: 31 - 88)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

polyethylene glycol

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: the vehicle was selected based on trial formulations performed at the testing labotatory and on test substance data supplied by the sponsor.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: according to OECD guideline 423

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality: twice daily; clinical observations: daily; bodyweight: Day 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No statistical analysis was performed (The method used is not intended to allow the calculation of a precise LD50 value).

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: According the OECD test guideline 423, Annex 2b, the LD50 was considered to exceed 5000 mg/kg body weight.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Hunched posture and/or piloerection was observed among all females on Day 1.

Gross pathology:

Necropsy revealed no substance-related findings.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

25 Mar - 11 Apr 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance glyceryl citrate/lactate/linoleate/oleate (CAS 91744-23-9). According to the ECHA guidance document ‘Practical guide 6: How to report read-across and categories' (ECHA, 2012), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 146 - 161 g (male); 130 - 142 g (female)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.004 cm³/kg

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

no statistics performed

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical symptoms occurred.

Gross pathology:

Necropsy revealed no treatment-related findings.

Other findings:

none

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Executive summary:

The acute oral toxicity of the test substance CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) to male and female Sprague-Dawley rats was investigated in a OECD 401 limit test under GLP conditions. The test substance was given to five animals per sex in a single dose of 2000 mg/kg bw.

Animals were examined for clinical signs up to 6 hours after the treatment. Thereafter, animals were daily observed for 14 consecutive days; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment. At the end of the 14 day observation period all animals were subject to necropsy.

During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD50 > 2000 mg/kg bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from two reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group, breakdown products, and similar physico-chemical and toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to the analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Source CAS 91052-13-0

In addition to the key study with source substance CAS 91052 -13 -0, acute dermal toxicity data is also available for source substance CAS 91744 -23 -9. For the latter source substance a LD50 value of > 2000 mg/kg bw was derived for male and female rats. Based on the study period the more recent study with CAS 91052 -13 -0 was selected as key study.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

As detailed in the analogue justification, it is considered that the target and the source substances are unlikely to lead to differences in acute toxicity potential. The oral LD50 value for both source substances CAS 91052-13-0 and CAS 91744-23-9 is > 2000 mg/kg bw. Therefore the target substance is also expected to have a very low level of acute dermal toxicity.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 Dec - 30 Dec 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP-Guideline study, tested with the source substance glycerides, C8-18 and C18-unsatd. mono- and di-, acetates (CAS 91052-13-0). According to the ECHA guidance document ‘Practical guide 6: How to report read-across and categories' (ECHA, 2012), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No. 8147, November 2000

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Remarks:

Crl:WI (Han) (outbred, SPF-Quality)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 277 - 304 g (males) and 184 - 202 g (females)
- Housing: individually housed in labelled Macrolon cages (Mlll type) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Nonham Mill Ltd), Surrey, UK).
- Diet: pelleted rodent diet (SM R/M-Z from SSNlFF® Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

occlusive

Vehicle:

polyethylene glycol

Details on dermal exposure:

TEST SITE
- Area of exposure: approx. 25 cm² on the dorsal area (males) and 18 cm² (females), respectively
- % coverage: 10%
- Type of wrap if used: dressing consisting of a surgical gauze patch (Surgy 1D, Laboratoires Stella sa., Liege, Belgium), successively covered with aluminum foil and Coban elastic bandage (3M, St. Paul, MN, USA.). A piece of Micropore tape (3M, St. Paul, MN, USA) was additionally used for fixation of the bandages in females only.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test substance was removed with tap water.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mL/kg bw
- Concentration (if solution): 200 mg/mL

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed twice daily for mortality and viability, and individual body weights were determined at Day 1 (pre-administration), 8 and 15; clinical signs were determined at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: Flat posture was noted among all animals on Day 1. Chromodacryorrhoea was observed in 3/5 males and in 2/5 females on Day 1. Ptosis was determined in 2/5 males and in 4/5 females. 3/5 females showed restless behaviour on Day 1. Scales and scabs of the rig

Gross pathology:

Necropsy revealed no substance-related findings.

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Reference 3

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

15 Apr - 02 May 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP guideline study, tested with the source substance glyceryl citrate/lactate/linoleate/oleate (CAS 91744-23-9). According to the ECHA guidance document ‘Practical guide 6: How to report read-across and categories' (ECHA, 2012), the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 200 - 300 g
- Fasting period before study: not mentioned
- Housing: conventional, each sex separately, not more than 5 animals/Makrolon cage type III
- Diet (e.g. ad libitum): Ssniff R-10 - Complete feed for rats ad libitum, supplied by Ssniff, Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: not mentioned
- % coverage: approx. 10
- Type of wrap if used: Acrilastik bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water and cellulose
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.004 ml/kg
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: not applicable

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations 0.5, 1, 2, 3, 4, 5 and 6 hours after application and then daily until day 14 after application; weighing on days 0 (day of application), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: examination of gross macroscopical organ changes

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 2 000 mg/kg bw

Mortality:

Number of deaths at each dose: 0/5 male; 0/5 female

Clinical signs:

other: none, nothing abnormal was detected on the skin in the application area

Gross pathology:

No alterations related to the test substance were noted

Other findings:

none

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

CLP: not classified

Executive summary:

The acute dermal toxicity of the test substance (CAS 91744-23-9, Glyceryl Citrate/Lactate/Linoleate/Oleate) to male and female Sprague-Dawley rats was investigated in a OECD 402 limit test under GLP conditions. The test substance was applied to the skin of five animals per sex in a single dose of 2000 mg/kg bw (semi-occlusive coverage). Total exposure was 24h. Thereafter, the test substance was removed using warm water and cellulose.

Animals were examined for clinical signs 0.5, 1, 2, 3, 4, 5 and 6 hours after treatment. Animals were thereafter daily observed for 14 consecutive days; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment. At the end of the 14 day observation period all animals were subject to necropsy.

During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD0 > 2000 mg/kg bw).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from two reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group, breakdown products, and similar physico-chemical and toxicological properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006.

Additional information

Justification for read-across

There are no data available on the acute oral, inhalation and dermal toxicity of glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7). The assessment of acute toxicity by the oral and dermal route was therefore based on studies conducted with analogue substances as part of a read across approach, in order to fulfil the standard requirements set out in Annex VII-VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. For the acute oral and acute dermal route, read-across was conducted with the structurally related analogue substances glycerides, C8-18 and C18-unsatd. mono- and di-, acetates (CAS 91052-13-0) and glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 91744 -23 -9). A statement on the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Acute oral toxicity

CAS 91052-13-0

The acute oral toxicity of glycerides, C8-18 and C18-unsatd. mono- and di-, acetates was investigated in an OECD guideline 423 study under GLP conditions (Riken, 2010a). In this study, 6 female Sprague Dawley rats were exposed to a limit dose of 2000 mg/kg bw in a stepwise procedure (3 rats per step). No mortality was observed up to the end of the14-day observation period. Clinical signs involved hunched posture and/or piloerection in all females on Day 1 of the observation period. All animals showed the expected gain in body weights during the study and necropsy revealed no substance-related findings. Based on the results, the oral LD 50 value for female Sprague Dawley rats is > 2000 mg/kg bw. In accordance with OECD guideline 423, the oral LD 50 cut-off of the test substance is considered to be > 5000 mg/kg bw.

 

CAS 91744-23-9

The acute oral toxicity of glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts to male and female Sprague-Dawley rats was investigated in an OECD 401 limit test under GLP conditions (Sasol, 1996a). The test substance was given to five animals per sex in a single dose of 2000 mg/kg bw. Animals were examined for clinical signs up to 6 hours after the treatment. Thereafter, animals were daily observed for 14 consecutive days; bodyweights were determined before treatment (day 0), and 7 and 14 days after treatment. At the end of the 14-day observation period all animals were subject to necropsy. During the study none of the animals died and animals did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance shows low toxicity (LD 50 > 2000 mg/kg bw).

 

Acute dermal toxicity

CAS 91052-13-0

The acute dermal toxicity of glycerides, C8-18 and C18-unsatd. mono- and di-, acetates was investigated in a limit test according to OECD guideline 402 and in compliance with GLP (Riken, 2010b). In this study, 5 male and 5 female rats were treated with the test substance at a dose of 2000 mg/kg bw. The test substance was dissolved in polyethylene glycol at a concentration of 200 mg/mL and applied onto the shaved skin of the test animals (10 mL/kg bw) for 24 h under occlusive conditions. After exposure, residual test substance was removed and animals were observed for a period of 14 days. No mortalities occurred and body weight gain of all animals was within the normal range during the whole study period. Flat posture was noted in all animals on Day 1. On the same day, chromodacryorrhoea was observed in 3/5 males and in 2/5 females. Ptosis was seen in 2/5 males and in 4/5 females, and 3/5 females showed restless behaviour on Day 1. Scales and scabs of the right flank and/or treated skin were observed among 3/5 males and 1/5 females between Days 4 and 15. At necropsy, no substance-related findings were noted. Therefore, the LD50 value in male and female rats is > 2000 mg/kg bw.

 

CAS 91744-23-9

The acute dermal toxicity of glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts to male and female Sprague-Dawley rats was investigated in an OECD 402 limit test under GLP conditions (Sasol, 1996b). The test substance was applied to the skin of five animals per sex in a single dose of 2000 mg/kg bw (semi-occlusive coverage). Total exposure was for 24h. Thereafter, the test substance was removed using warm water and cellulose. Animals were examined for clinical signs 0.5, 1, 2, 3, 4, 5 and 6 hours after treatment. Animals were thereafter daily observed for 14 consecutive days; bodyweights were determined before treatment (Day 0), and 7 and 14 days after treatment. At the end of the 14-day observation period all animals were subject to necropsy. During the study, none of the animals died and animals did not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the LD50 value is > 2000 mg/kg bw in male and female rats.

 

Overall conclusion for acute toxicity

The reliable data available for the analogue substances glycerides, C8-18 and c18-unsatd. mono- and di-, acetates (CAS 91052-13-0) and glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts (CAS 91744-23-9) indicate a low level of acute toxicity following the oral and dermal route, as LD50 values were greater than the currently applied limit values. Therefore, as the available data of the structural analogue substances did not identify any hazard for acute toxicity, glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) is not expected to be hazardous following acute exposure.

Justification for classification or non-classification

Based on read-across from structurally similar substances, the available data on oral and dermal toxicity do not meet the classification criteria according to Regulation (EC) No. 1272/2008 (CLP), and are therefore conclusive but not sufficient for classification.