Registration Dossier

Diss Factsheets

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:
other: OECD Guideline study performed under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

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:
Cystine
EC Number:
200-296-3
EC Name:
Cystine
Cas Number:
56-89-3
Molecular formula:
C6H12N2O4S2
IUPAC Name:
cystine
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
dressing: gauze and non-irritating tape
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 male and 5 female
Control animals:
not required

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
other: No signs of toxicity. Scratches were observed in one male animal. These signs of irritation were not reversible within the observation period (14 days).
Gross pathology:
No special findings
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the condition of the present study, single dermal application of the test item L-Cystine to rats at a dose of 2000 mg/kg body weight was
associated with neither mortality nor signs of toxicity but slight signs of irritation.
Executive summary:

The dermal LD50 was determined to be > 2000 mg L-Cystine / kg body weight.