Butyl carbamate

Endpoint summary

Description of key information

The test substance was not irritating to the skin, but was severely irritating to the eyes of rabbits.

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

Study period:

From February 09, 1988 to February 10, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Butylurethan
- Purity: approx. 94% (impurities: 5.5% dibutyl carbonate, 0.6% n-butanol).
- 500 mg carbamic acid butyl ester (mixed into a paste with 0.18 mL polyethylene glycol 400).

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Weight: 2.9 - 3.3 kg
Age: 3 - 5 months
Room temperature: 20 +/- 3°C; Humidity: 50 +/- 20%
Light/dark period: 12/12h
Food: Altromin 2123 Haltungsdiat (ad libitum); Water: deionized (ad libitum)

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Remarks:

depilated

Vehicle:

other: Polyethylene glycol 400

Amount / concentration applied:

500 mg in 0.18 mL (PEG 400).

Duration of treatment / exposure:

4 hours

Observation period:

1/2, 1, 24, 48 and 72 hours after removal of the adhesie dressing

Number of animals:

3

Irritation parameter:

erythema score

Basis:

animal: 1 and 2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 30 min to 24 h

Score:

1

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 48 and 72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal: 1, 2 and 3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

From 30 minutes to 24 hours after removal of the patch, one animal showed very mild erythema.
As of 48 hours after patch removal, none of the animals had signs of irritation.

Conclusions:

Under the study conditions, the test substance was considered to be not irritating to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation/corrosion potential of the test substance (94% purity) in rabbit according to to OECD Guideline 404 and EU Method B.4. Three New-Zealand White rabbits were exposed to 500 mg (in 0.18 mL PEG 400) for 4 h (semi-occlusive coverage on shaved skin). At the end of the exposure period, the bandage was removed and the skin carefully cleaned with warm water. Effects were recorded at 30 and 60 minutes, then after 24, 48 and 72 h. From 30 min to 24 h after removal of the patch, one animal showed very mild erythema. As of 48 h after patch removal, none of the animals had signs of irritation (in terms of erythema, scab formation and oedema). Under the study conditions, the test substance was considered to be not irritating to rabbit skin (Kreiling and Jung, 1988).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From February 16, 1988 to February 23, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

- Butylurethane
- Purity: approx. 94% (impurities: 5.5% dibutyl carbonate, 0.6% n-butanol).
- 100 mg dose

Species:

rabbit

Strain:

New Zealand White

Remarks:

Albino

Details on test animals or tissues and environmental conditions:

Weight: 2.1 - 3.3 kg
Age: 3 - 5 months
Room temperature: 20 +/- 3°C; Humidity: 50 +/- 20%
Light/dark period: 12/12h
Food: Altromin 2123 Haltungsdiat (ad libitum); Water: deionized (ad libitum)

Vehicle:

physiological saline

Remarks:

at 37°C

Controls:

yes

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

24 h

Observation period (in vivo):

1, 24, 48, 72 h and 7 days after exposure and washing

Number of animals or in vitro replicates:

3

Details on study design:

A single dose of the test substance was instilled into the cojunctival sac of the left eye.
About 24 h before the start of the experiment, a solution of sodium fluorescein (0.01%) was applied on the cornea in order to assess potential cornea damages.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.7

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7d

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.3

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Observations:
From 1 to 72 h after instillation, the iris was reddened in all of the animals.
One hour to 7 d after instillation, the animals' conjuctivae were slightly swollen to swollen, the eyelids being more than half-closed, and there was hyperaemia which ranged from marked hyperarmia of some of the blood vessels to a diffuse, intense red colour.
The animals' corneas exhibited white discoloration and haemorrhage. Seven days after instillation, all animals were observed to have early or advanced stages of vascularization.
Cornea damages were evaluated in a test with fluorescein with individual scores ranging from 1 to 4 after 24 and 72 h, and 7 d.

Interpretation of results:

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

Conclusions:

Under the study conditions, the test substance was considered to be severely irritating to rabbit eye.

Executive summary:

A study was conducted to determine the eye irritation potential of the test substance (94% purity) in rabbit according to OECD Guideline 405 and EU Method B.5. The left eye of three New-Zealand White rabbits was exposed to 100 mg of the test substance for 24 h. The right eye remained untreated and served as negative control. After 24 h, the eyes were washed and observations for effects on the cornea, iris and conjunctiva were realized at 1, 24, 48, 72 h and 7 days. The untreated eye served as control. From 1 to 72 h after instillation, the iris was reddened in all of the animals. One hour to 7 days after instillation, conjuctivae were slightly swollen to swollen, the eyelids being more than half-closed, and there was hyperaemia (from marked hyperaemia of some of the blood vessels to a diffuse, intense red colour). The corneas exhibited white discoloration and haemorrhage. Seven days after instillation, all animals were observed to have early or advanced stages of vascularization. Under the study conditions, the test substance was considered to be severely irritating to rabbit eye (Kreiling and Jung, 1988).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A study was conducted to determine the skin irritation/corrosion potential of the test substance (94% purity) in rabbit according to to OECD Guideline 404 and EU Method B.4. Three New-Zealand White rabbits were exposed to 500 mg (in 0.18 mL PEG 400) for 4 h (semi-occlusive coverage on shaved skin). At the end of the exposure period, the bandage was removed and the skin carefully cleaned with warm water. Effects were recorded at 30 and 60 minutes, then after 24, 48 and 72 h. From 30 min to 24 h after removal of the patch, one animal showed very mild erythema. As of 48 h after patch removal, none of the animals had signs of irritation (in terms of erythema, scab formation and oedema). Under the study conditions, the test substance was considered to be not irritating to rabbit skin (Kreiling and Jung, 1988).

Eye irritation

A study was conducted to determine the eye irritation potential of the test substance (94% purity) in rabbit according to OECD Guideline 405 and EU Method B.5. The left eye of three New-Zealand White rabbits was exposed to 100 mg of the test substance for 24 h. The right eye remained untreated and served as negative control. After 24 h, the eyes were washed and observations for effects on the cornea, iris and conjunctiva were realized at 1, 24, 48, 72 h and 7 days. The untreated eye served as control. From 1 to 72 h after instillation, the iris was reddened in all of the animals. One hour to 7 days after instillation, conjuctivae were slightly swollen to swollen, the eyelids being more than half-closed, and there was hyperaemia (from marked hyperaemia of some of the blood vessels to a diffuse, intense red colour). The corneas exhibited white discoloration and haemorrhage. Seven days after instillation, all animals were observed to have early or advanced stages of vascularization. Under the study conditions, the test substance was considered to be severely irritating to rabbit eye (Kreiling and Jung, 1988).

Justification for classification or non-classification

Based on the results of in vivo testing, the substance is not considered to be irritating to skin and does not require any classification for this endpoint according to the CLP criteria (EC 1272/2008). However, severe effects were observed in eye irritatiion testing in vivo, so that classification as Eye Damage 1 is warranted.