Butyl chloroformate

Endpoint summary

Description of key information

In a skin irritation/corrosion and an eye irritation test the test substance was found to be corrosive to the skin and eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP non-guideline, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Principles of method if other than guideline:

According to BASF-internal standard. The test substance (ca. 0.5 g) was applied to a 2.5 x 2.5 cm application site of white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions. The skin was left intact. Animals were observed for 8 days and skin changes were observed. Findings were recorded after 24 hours and at the end of the observation period. Findings were graded as described in OECD test guideline 404.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

- Weight at study initiation: Male animal 3.24 kg, Female animal 2.53 kg

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin of the same animal

Amount / concentration applied:

Undiluted

Duration of treatment / exposure:

1 min, 5 min, 15 min, 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

- The test substance was washed off after the appropriate exposure time with Lutrol/water (1:1)

Irritation parameter:

erythema score

Basis:

animal: #1 and #2

Time point:

other: 24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 5 min, 15 min and 20 hr exposure. Necrosis after 8 days

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 5 min, 15 min and 20 hr exposure. Induration after 8 days

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 h

Score:

0

Max. score:

4

Remarks on result:

other: 5 min and 15 min

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 hr exposure. Transverse folds after 8 days

Irritant / corrosive response data:

- 1 minute exposure: After 24 hours marked erythema was observed in both animals. These effects were not reversible within 8 days. In addition marked scaling was observed on both animals after 8 days.
- 5 and 15 minute exposure: After 24 hours marked erythema was observed in both animals and slight edema in animal #1. The observed erythema was not reversible within 8 days. In addition necrosis was observed in animal #1 and hardening of the skin in both animals.
- 20 hour exposure: After 24 hours marked erythema was observed in both animals and slight edema in animal #1 and strong edema in animal #2. The observed erythema was not reversible within 8 days. In addition necrosis was observed in both animals and transverse folds were present in the skin in both animals.

Interpretation of results:

corrosive

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

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: Non-GLP non-guideline, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment.

Principles of method if other than guideline:

According to BASF-internal standard. The eye irritating potential of the test substance was examined in 2 rabbits. The animals were exposed to about 0.05 mL of the test substance. Effects were scored according to the method of Draize. Observations were made after 1, 24 hour and 8 days.

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

- Weight at study initiation:Animal #1: 2.7 kg, animal #2: 2.48 kg

Vehicle:

unchanged (no vehicle)

Controls:

other: NaCl treated eye of the same animal

Amount / concentration applied:

0.05 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

2

Details on study design:

The test substance was not washed off.

Irritation parameter:

chemosis score

Basis:

animal: #1 and #2

Time point:

other: 24 h

Score:

2

Max. score:

3

Reversibility:

other: after 8 days staphyloma, injected vessels

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2

Time point:

other: 24 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Irritant / corrosive response data:

After 1 hour, marked redness and corneal opacity was observed in both animals. Marked chemosis in animal #1 and severe chemosis in animal #2 was noted.
After 24 hours, marked chemosis and corneal opacity was observed in both animals. Hemorrhages were also observed in both animals. In addition iritis was present in both animals
After 8 days: Slight redness and slight to marked corneal opacity present in both animals. In addition, staphyloma and ingrowing vessels were observed in both animals.

Interpretation of results:

corrosive

Remarks:

Migrated information

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

In a skin irritation / corrosion study (BASF 1970) the test substance was applied to two white Vienna rabbits for 1 min, 5 min, 15 min and 20 h under occlusive conditions. Animals were observed for 8 days and skin changes were observed. Findings were recorded after 24 hours and at the end of the observation period. After 24 hours (5 -15 min exposure) marked erythema was observed in both animals and slight edema in animal #1. The observed erythema was not reversible within 8 days. In addition necrosis was observed in animal #1 and hardening of the skin in both animals. At 24 hours (after 20 h exposure) marked erythema was observed in both animals and slight edema in animal #1 and strong edema in animal #2. The observed erythema was not reversible within 8 days. In addition, necrosis was observed in both animals and transverse folds in the skin in both animals.

Eye irritation

In an eye irritation study (BASF 1970) two Vienna white rabbits were exposed to 0.05 mL of the test substance followed by an observation period of 8 days. Observations were made after 1 hour, 24 hour and 8 days. After 1 hour, marked redness and corneal opacity was observed in both animals. In addition, marked chemosis in animal #1 and severe chemosis in animal #2 was noted. After 24 hours, marked chemosis and corneal opacity was observed in both animals. Hemorrhages were also observed in both animals. In addition, iritis was present in both animals After 8 days, slight erythema and slight to marked corneal opacity were present in both animals. In addition, staphyloma and ingrowing vessels were observed in both animals.

Justification for selection of skin irritation / corrosion endpoint:
One skin irritation / corrosion study is available. This study is adequate for covering this endpoint.

Justification for selection of eye irritation endpoint:
One eye irritation study is available. This study is adequate for covering this endpoint.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the severity and irreversibility of the observed effects, the test substance is classified as Skin corrosive category 1B, H314: Causes severe skin burns and eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.

Because severe eye effects (staphyloma) were observed after ocular application at a concentration half the amount required in the OECD 405 guideline, the test substance has to be classified as Eye damage 1: H318: Causes serious eye damage in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.