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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed GLP and OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-amino-2-chlorotoluene-4-sulphonic acid
EC Number:
201-839-7
EC Name:
5-amino-2-chlorotoluene-4-sulphonic acid
Cas Number:
88-53-9
Molecular formula:
C7H8ClNO3S
IUPAC Name:
2-amino-5-chloro-4-methylbenzene-1-sulfonic acid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, company breeding colony
- Strain: Albino New Zealand rabbit, normal breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 3.4 - 3.9 kg
- Housing: single cages arranged in a battery
- Diet: Altromin 2123 ad libitum + straw
- Water : de-ionized and chlorinated water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 50 +/- 20
- Lighting time: 12 h daily

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eyes served as control
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
7 days after beginning of treatment
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #72, 77, 79 each
Time point:
other: mean of 24, 48, 72 h reading
Score:
0
Max. score:
4
Reversibility:
other: initial slight signs of irritation (cornea) were fully reversible within 24h
Irritation parameter:
iris score
Basis:
animal: #72, 77, 79 each
Time point:
other: mean of 24, 48, 72 h reading
Score:
0
Max. score:
2
Reversibility:
other: initial slight signs of irritation (iris) were fully reversible within 24h
Irritation parameter:
conjunctivae score
Basis:
animal: #72
Time point:
other: mean of 24, 48, 72 h reading
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal: #77
Time point:
other: mean of 24, 48, 72 h reading
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #79
Time point:
other: mean of 24, 48, 72 h reading
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal: #72
Time point:
other: mean of 24, 48, 72 h reading
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: #77
Time point:
other: mean of 24, 48, 72 h reading
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal: #79
Time point:
other: mean of 24, 48, 72 h reading
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
discharge at the 1 h reading was fully reversible within 24 h.
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test results the substance does not meet criteria for classification concerning serious eye damage/eye irritation as laid down in Regulation (EC) No 1272/2008.
Executive summary:

Test material was subject to a test of serious eye damage/eye irritation according to OECD Guideline 405. 100 mg of substance were applied to one eye of each of three animals. Mean values of the 24, 48 and 72 h readings were calculated for each animal. Only slight effects (conjunctival redness mean score: <=1.7, conjunctival chemosis mean score: <=0.7, corneal opacity mean score: 0, and iritis mean score: 0) below the threshold for classification were determined. All effects were fully reversible. Based on these findings the test material was judged not to be seriously eye damaging or eye irritating.