Registration Dossier

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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics" by the Staff of the Division of Pharmacology, FDA, interpretation of results according to Draize, 1959 and OECD Guidelines of May 1981
Deviations:
no
GLP compliance:
yes
Remarks:
Although the study predates GLP, the appendix in the report states that the experiment was carried out in accordance with GLP and OECD Guidelines.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Test material: Simazine Technical
- Description: White powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 6 to 8 months old
- Weight at study initiation: about 3.0 kg
- Housing: individual cages
- Diet: standard diet
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C ± 2°C
- Humidity (%): 50 - 60%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g of the test substance was instilled into one eye of each animal
Observation period (in vivo):
The animals remained in their cages for 8 hours. Ocular lesions were read up to 7 days after administration.
Number of animals or in vitro replicates:
6 rabbits were used in the study
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: All animals
Time point:
other: All time points
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: All animals
Time point:
other: All time points
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
other: All animals
Time point:
other: All time points
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
other: All animals
Time point:
other: All time points
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
other: conjunctivae: lacrimation
Basis:
other: All animals
Time point:
other: 1 and 2 hours
Score:
1
Reversibility:
fully reversible within: 4 hours
Remarks on result:
other: Conjunctival irritation with slight increased secretion was only observed during the first two hours of the experiment.
Irritant / corrosive response data:
The animals showed conjunctival irritation with slight increased secretion during the first two hours of the experiment. After 4 hours these differences had disappeared.

All other scores determined during the study were zero.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance, Simazine Technical, is evaluated as a "non-irritant" to eyes under the conditions of the study.