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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Scientifically undertaken and reported study but not to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chlorendic anhydride- Analytical purity: 98.81%- Lot/batch No.: 3-12-206

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS- Source: Sweetwater Farms, Hillsboro, Ohio- Age at study initiation: - Weight at study initiation: 2049 to 2523 g- Housing: hanging wire-mesh cages.- Diet: Purina Rabbit Chow, ad libitum - Water: ad libitum- Acclimation period:ENVIRONMENTAL CONDITIONS- Temperature (°C): - Humidity (%): - Air changes (per hr): - Photoperiod (hrs dark / hrs light):IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as a control for each rabbit.
Amount / concentration applied:
TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 mg- Concentration (if solution):VEHICLE- Amount(s) applied (volume or weight with unit):- Concentration (if solution):- Lot/batch no. (if required): - Purity:
Duration of treatment / exposure:
14 days following instillation.
Observation period (in vivo):
14 days following instillation.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE- Washing (if done): None- Time after start of exposure:SCORING SYSTEM: J.H. Draize scale for scoring ocular lesions.TOOL USED TO ASSESS SCORE: Fluorescein and UV lamp.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 14 days
Score:
16.4
Max. score:
17.3
Reversibility:
not specified

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated informationCriteria used for interpretation of results: not specified
Conclusions:
Based upon the data, the test material would be considered a primary eye irritant.