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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
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
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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 / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0,1 g
Duration of treatment / exposure:
The treated eye was not rinsed 24 hours after the application.
Observation period (in vivo):
The animals were observed for 72 hours after dosing.
Number of animals or in vitro replicates:
3
Details on study design:
The untreated contralateral eye served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
ca. 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
ca. 0
Other effects:
Neither mortality nor significant clinical signs of toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present study, a single ocular application of the test item L-Cystine at a dose of 0,1 g produced irritant effects, which were fully reversible within 72 hours.
Executive summary:

Under the conditions of the present study, a single ocular application of the test item L-Cystine to rabbits at a dose of 0.1 g produced irritant effects, which were fully reversible within 72 hours. Neither mortalities nor significant clinical signs of toxicity were observed.

In conformity with the EC criteria for classification and labelling requirements for dangerous substances and preparations according to Annex VI of Commission Directive 2001/59/EC, the test item L-Cystine has no obligatory labelling requirement for eye irritation.

According to Annex I of Regulation (EC) 1272/2008, the test item L-Cystine has no obligatory labelling requirement for eye irritation.

According to GHS (Globally Harmonized Classification System) the test item L-Cystine has no obligatory labelling requirement for eye irritation.

Neither mortality nor significant clinical signs of toxicity were observed.

The test item L-Cystine has no obligatory labelling requirement for eye irritation.