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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
Study period:
1978 June - October
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Test performed by nationally accredited lab with well-defined protocol.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 16 CFR 1500.42
Principles of method if other than guideline:
- Principle of test: Test substance was applied to the eyes of animals for 30 seconds. The animals were observed for ocular lesions at 24, 48, and 72 hours after instillation of test material.
- Short description of test conditions: Healthy rabbits received 0.1 ml of test material in one eye. Eyes were washed with 20 ml of distilled water for 30 seconds after instillation.
- Parameters analysed / observed: Lesions to the cornea, iris, and conjunctivae. Conjunctivae were evaluated for redness and chemosis.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
NL Industries
- Expiration date of the lot/batch:
Lot # 60-8313-01
- Purity test date:
N/A

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Not reported
- Stability under test conditions: Assumed to be stable
- Solubility and stability of the test substance in the solvent/vehicle:
N/A
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
N/A

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
Used as received
- Preliminary purification step (if any):
None
- Final dilution of a dissolved solid, stock liquid or gel:
N/A
- Final preparation of a solid:
N/A

FORM AS APPLIED IN THE TEST (if different from that of starting material)
: 5000 mg/kg

TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable)
: N/A

OTHER SPECIFICS:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Summit View Farms, Belvidere, New Jersey, USA
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Ad libitum Purina rabbit chow
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: To: Not reported

Test system

Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): N/A

VEHICLE
- Amount(s) applied (volume or weight with unit): N/A
- Concentration (if solution): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A
Duration of treatment / exposure:
30 s
Observation period (in vivo):
72 hr (data recorded every 24 hr)
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): With and without irrigation with distilled water
- Time after start of exposure: 30 s

SCORING SYSTEM: Lesions to the cornea, iris, and conjunctivae. For the cornea, scores ranged from 0-4, with 0 being no ulceration or opacity, and 4 being complete corneal opacity with iris not discernible. For the iris, scores ranged from 0-2, with 0 being normal, and 2 being no reaction to light, hemorrhage, gross destruction, or all of the above. Lesions to the conjunctivae were scored separately for redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) and chemosis. For redness, scores ranged from 0-3, with 0 being normal vessels, and 3 being diffuse beefy red. For chemosis, scores ranged from 0-4, with 0 being no swelling, and 4 being swelling with lids more than half closed.

TOOL USED TO ASSESS SCORE: gross observation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
no wash
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
80
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
no wash
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
10
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
no wash
Basis:
mean
Time point:
24 h
Score:
2
Max. score:
30
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
conjunctivae score
Remarks:
no wash
Basis:
mean
Time point:
48 h
Score:
0.5
Max. score:
30
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
no wash
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
wash
Basis:
mean
Time point:
24 h
Score:
0.66
Max. score:
1
Irritation parameter:
cornea opacity score
Remarks:
wash
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Remarks:
wash
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was evaluated under the criteria defined by 16 CFR 1500.42 for eye irritation in vivo. While the test substance was determined to be an ocular irritant by these criteria, it does not meet the criteria of Regulation EC No. 1272/2008 for classification of eye irritation.