Simazine

Eye irritation

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

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

Test material information

Constituent 1

Reference substance name:

Simazine

EC Number:

204-535-2

EC Name:

Simazine

Cas Number:

122-34-9

Molecular formula:

C7H12ClN5

IUPAC Name:

6-chloro-N2,N4-diethyl-1,3,5-triazine-2,4-diamine

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: All animals

Time point:

other: All time points

Score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

other: All animals

Time point:

other: All time points

Score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: All animals

Time point:

other: All time points

Score:

0

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

other: All animals

Time point:

other: All time points

Score:

0

Remarks on result:

no indication of irritation

Results 5

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.