Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment with restrictions (no individual irritation scores given)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Principles of method if other than guideline:
Test according to the method described in § 1500.41 in the Federal Register 38, No. 187, 1973, page 27019 (Draize test).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Echtorange GR Base = 2-nitro-1-aminobenzol
- Analytical purity: 98.5-99.5% base

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: SPF-Albino-Himalayan rabbits, Hoe:HIMK (SPFWiga)
- Housing: 1/cage
- Diet (ad libitum): Erka 8300 (Robert Koch oHG/Hamm, Germany)
- Water (ad libitum): tap water

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent eye remained untreated and served as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with physiological saline
- Time after start of exposure: 24 hrs

SCORING: after 1, 7, 24, 48, and 72 hours

SCORING SYSTEM: according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics", FDA, Austin, Texas, p. 51, 1975

TOOL USED TO ASSESS SCORE: loupe, fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 hrs
Score:
22
Max. score:
110
Reversibility:
not specified

Any other information on results incl. tables

According to the FDA guidelines, the test substance was slightly irritating to the eye under the conditions of the test.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU