sec-butyl chloroformate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, 50 μl instead of 100 μl test substance instilled). Study sufficient for evaluation of this endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

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 50 µl 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:

sec-butyl chloroformate

EC Number:

241-475-6

EC Name:

sec-butyl chloroformate

Cas Number:

17462-58-7

Molecular formula:

C5H9ClO2

IUPAC Name:

butan-2-yl carbonochloridate

Constituent 2

Reference substance name:

sec-Butylchloroformate

IUPAC Name:

sec-Butylchloroformate

Constituent 3

Reference substance name:

XIX 353

IUPAC Name:

XIX 353

Details on test material:

- Name of test material (as cited in study report): sek. Butylchlorkohlensaeureester (sec. butyl carbonochloridic acid ester)- Physical state: liquid - Analytical purity: ca. 95 % - 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: 2.63 and 2.64 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):

8 d

Number of animals or in vitro replicates:

2 (one male, one female)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

1.25

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: Effects strengthened over time; see table for further details

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

0.5

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: Irreversible iritis in 1/2 animals; see table for further details

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: see table for further details

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 48 h

Score:

1.25

Max. score:

2

Reversibility:

fully reversible within: 5 d

Remarks on result:

other: see table for further details

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Comment
1	1 h	1	0	2	2
2	1 h	1	0	1	2
1	3 h	1	0	2	3
2	3 h	1	0	2	3
1	24 h	2	0	2	2
2	24 h	1	0	2	2
1	48 h	1	2	2	0	blood, lubricious secretion, alopecia
2	48 h	1	0	2	1
1	5 d	3	2	2	0	blood, necrosis
2	5 d	3	0	2	0	blood, necrosis
1	7 d	3	2	2	0	blood, necrosis
2	7 d	3	0	2	0	blood, necrosis
1	8 d	3	2	2	0	blood, necrosis, alopecia
2	8 d	3	0	2	0	blood, necrosis, alopecia
mean	24 - 48 h	1.25	0.50	2.00	1.25

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information

Executive summary:

The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation, 50 µl instead of 100 µl test substance instilled). The study is however sufficient for evaluation of this endpoint. Corneal opacity, iritis (in 1/2 animals), conjunctivae redness and chemosis were observed and partially  increased over time.

Conclusion

sec-Butylchloroformate exhibit the risk of serious eye damage (R41 following to EU classification criteria and eye irritation/ corrosion Cat. 1 following GHS criteria)