4-tert-butylcyclohexyl chloroformate

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:

other: see 'Remark'

Remarks:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 μl instead of 100 μl test substance instilled; scoring system not according to OECD405). Study sufficient for evaluation of this endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1969

Report date:

1969

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

scoring system; application volume

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test). White Vienna rabbits were used. Usually 50µl or mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. The non- or saline-treated adjacent eye served as a control.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-tert-butylcyclohexyl carbonochloridic acid ester

IUPAC Name:

4-tert-butylcyclohexyl carbonochloridic acid ester

Constituent 2

Reference substance name:

XVIII/369

IUPAC Name:

XVIII/369

Details on test material:

- Name of test material (as cited in study report): 4-tert.-ButylcyclohexylchlorKohlensäureester ( 4-tert-butylcyclohexyl carbonochloridic acid ester)
- Physical state: clear liquid
- Analytical purity: 98 %
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2,87 Kg and 2,17 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: one drop of saline into the other eye

Amount / concentration applied:

50 µl

Duration of treatment / exposure:

Treatment was once. The eye was left unwashed.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

2 (one male, one female)

Results and discussion

Any other information on results incl. tables

Time post application	Rabbit 1	Rabbit 2
1 h	Erythema +	Erythema ++
24 h	Erythema ++	Erythema +
48 h	Erythema + Cornea damage (+)	Erythema + Cornea damage (+)
72 h	Ø	Erythema + Cornea damage (+)
8 days	Ø	Ø

Applicant's summary and conclusion

Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 50 μl instead of 100 μl test substance instilled; 2 insteatd of 3 animals; scoring system not according to OECD405).

Due to the maked erythema in both rabbits in the first 24 h and the questional reversable cornea demage (fluoresein staining) the test substance is classified as irritating to the eyes. These effects developed after application of only 50 µl instead of 100 µl as demanded by OECD 405.