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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(2S,4S)-4-(phenylsulfanyl)pyrrolidine-2-carboxylic acid
EC Number:
617-252-8
Cas Number:
81653-77-2
Molecular formula:
C11H13NO2S
IUPAC Name:
(2S,4S)-4-(phenylsulfanyl)pyrrolidine-2-carboxylic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
The female animales were nulliparous and non-pregnant.
Body weight at the beginning of thè study - females: 211 - 225 g, males 215 - 228 g
Age at the beginning of the study - females:approximately 13 weeks old, males:approximately 13 weeks old

Housing and Feeding Conditions
Semi-banier in an air-conditioned room
Temperature: 22 ± 3 °C
Relative humidity: 55 ± 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice
Free access to tap water, sulphur acidified to a pH vaine of approx. 2.8
(drinking water, municipal residue control, microbiologically controlled at frequent intervals)
The animals were kept in IVC cages, type III H, polysulphone cages on Altromin saw fiber bedding

Adequate acclimatisation period (at least five days)

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
Approximately 24 hours before the test, the lur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used.
No less than 10% of the body surface was cleared for the application.
Prior to the application a detailed clinical observation was made of all animals.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing nd non-imtating tape and was fixed with an additional dressing in a suitable manner.
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
All of the animals were observed for 14 days after dosing.
Signs of erythema and oedema were assessed using the scoring System laid down in OECD Guideline 404.
Weight Assessment
The animals were weighed prior to the application, once a week thereafter and at the end of thè study.
Clinical Examination
A careful clinical examination was made at least twice on thè day of dosing and once a day thereafter until day 14.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomie and central nervous systems and somatomotor activity and behaviour patte were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Pathology
At the end of the study period the animals were sacrificed by an overdosage of pentobarbital.
All of the animals were subjected to gross necropsy. All gross pathological changes were recorded.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
other: No treatment-related effects were observed.
Gross pathology:
No treatment-related effects were observed.
Other findings:
No treatment-related effects were observed.

Applicant's summary and conclusion

Conclusions:
The dermal LD50 was determined to be > 2000 mg/kg
Executive summary:

A single dennal application of the test item to rats up to a dose of 2000 mg/kg body weight was not associated with signs of toxicity nor mortality.

The dermal LD50 was determined to be > 2000 mg/kg.