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Administrative data

Description of key information

oral LD50 > 5000 mg/kg bw
dermal LD50 > 2000 mg/kg bw
The substance has very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Furthermore the results of laboratory animal studies show low acute oral and dermal toxicity for the substance. This intrinsic property/toxicity potential can be extrapolated to acute inhalative route administration.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Morini - S. Polo d'Enza (RE), Italy
- Age at study initiation: no data
- Weight at study initiation: 190 - 220 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C +- 2 °C
- Humidity (%): 55 +- 15 %
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-June-1992 To: 16-06-1992
Route of administration:
oral: gavage
Vehicle:
other:
Remarks:
(sesame seed oil)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 500 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
5000 mg/kg bw administered by stomach tube
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:
Mortality: every morning in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of organic bodys functions, tegumentary apparatus, mucosae conditions, somatomotor activity and sensorium conditions): daily
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs
Body weight:
Body weight gain was normal.
Gross pathology:
No effects on organs were found.
Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 in rats of Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)]-, C12-13-branched alkyl esters was greater than 5000 mg/kg bw.
Executive summary:

An acute oral toxicity test was carried out on a group of 10 rats (5 male and 5 female) using test material according to OECD guideline 401. The test material Butanedioic acid, 2,3-dihydroxy-[R-(R*, R*)]-, C12-13-branched alkyl esters was administered at a dose of 5000 mg/kg by using a stomach tube. There were no cases of mortality and no toxicological signs during the study. The LD50 was greater than 5000 mg/kg bw and the test material was found to be non-toxic under experimental conditions.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
Klimisch 1

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Nossan, Correzzana MI, Italy
- Age at study initiation: no data
- Weight at study initiation: 180 - 200 g
- Fasting period before study: not mentioned
- Housing: in groups of 5 per sex per cage (polycarbonate, dimensions 425x266x180 mm)
- Diet (e.g. ad libitum): standard pellet complete diet ad libitum
- Water (e.g. ad libitum): filtered tap water ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 2 °C
- Humidity (%): 55% +- 15 % R.H.
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17-Nov-1993 To: 01-Dec-1993
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Treatment
Skin preparation
Approximately 24 hours before the test fur was removed by clipping and shaving a dorsal area about 25 cm2 wide.The patch was removed 24 hours after application.

TEST SITE
- Area of exposure: 25 m2 wide
- % coverage: The sample was put on a patch (Hansamed strips) the dorsal area of animals. The patch was then impermeable and hypoallergenic plastic adhesive 3M)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exceeding material was then washed away from skin using a pad soaked in distilled water.
- Time after start of exposure: no data



Duration of exposure:
no data
Doses:
2000 m/kg bw at a volume of 10 mL/kg.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
Mortality: daily in the working week (5 out of 7 days)
Clinical symptoms (including evaluation of body functions, tegumentary apparatus, mucosae conditions, respiratory activity, sensorium conditions): not mentioned
Body weight: before the experiment, at day 7 and 14
- Necropsy of survivors performed: yes
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2 mL/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2 mL/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: None
Body weight:
Body weight gain was normal during the study
Gross pathology:
During the necropsy in rat female n. 3 a sub-capsular cyst was observed in the right kidney. The anomaly is not ascribable to the treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 dermal in the rat was greater than 2000 mg/kg bw.
Executive summary:

The test of acute dermal toxicity was performed on a group of ten rats (5 male and 5 female) according to EEC Directive 92/69. The test material Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters alkyl esters, was administered at a dose of 2000 mg/kg bw by dermal application. During the study no case of mortality occurred. No clinical symptoms were observed, the body weight gain was normal for the used species. The LD50 was greater than 2000 mg/kg bw and Butanedioic acid, 2,3-dihydroxy- [R-(R*,R*)]-, C12-13-branched alkyl esters was found to be non-toxic under experimental conditions.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch 2

Additional information

Justification for classification or non-classification

No classification for acute toxicity is indicated according to the classification, labeling and packaging (CLP) regulation (EC 1272/2008).

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