Registration Dossier

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: GLP-study according to OECD guideline 405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): sulfanilic acid
- Physical state: light grey solid
- Analytical purity: > 98.5%
- Lot/batch No.: oohl-NFC 001

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Housing:
The animals were singly housed in suspended stainless steel caging with mesh floors which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals (Natl. Res. Council, 1996). Litter paper was placed
beneath the cage and was changed at least three times per week.

Animal Room Temperature and Relative Humidity Ranges: 18-22ºC and 33-69%, respectively.
Photoperiod: 12-hour light/dark cycle
Acclimation Period: 5 or 12 days
Food: Pelleted Purina Rabbit Chow #5326
Water: Filtered tap water was supplied ad libitum by an automatic water dispensing system.
Contaminants: There were no known contaminants reasonably expected to be found in the food or water at levels which would have interfered with the results of this study. Analyses of the food and water are conducted regularly and the records are kept on file at Eurofins PSL.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
1 ml
Duration of treatment / exposure:
21 d
Observation period (in vivo):
21 d
Number of animals or in vitro replicates:
3
Details on study design:
First one rabbit was tested and subsequently two further rabbits were used.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
result
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.66
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 14 days
Other effects:
All animals appeared active and healthy during the study. Apart from the eye irritation noted,
there were no other signs of gross toxicity, adverse pharmacologic effects, or abnormal behavior.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes) based on GHS criteria
Remarks:
Migrated information
Conclusions:
In a GLP-study according to OECD test guideline 405, the registered substance is severly eye irritating, but all effects reverse latest after 21 days.
Executive summary:

In a GLP-study according to OECD test guideline 405, the registered substance is severly eye irritating, but all effects reverse latest after 21 days.