Butyl vinyl ether

Endpoint summary

Description of key information

The undiluted BVE was irritating to the rabbit skin but was not irritant to the rabbit 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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

adopted 1992

GLP compliance:

yes

Remarks:

(BASF AG, Dep. of Toxicology)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Thomae GmbH (FRG)
- Age at study initiation: young adult, no further data
- weight at study initiation: 3.73 (male), 3.98 (female), and 3.99 (females) kg
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin

Amount / concentration applied:

0.5 mL undiluted TS

Duration of treatment / exposure:

4 hour(s)

Observation period:

1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches

Number of animals:

3

Details on study design:

The fur was clipped at least 24 hrs before treatment.
Application: A pad (2.5 cm x 2.5 cm) soaked with 0.5 mL of undiluted TS was placed to the shaved, intact rabbit's dorsal skin (secured by semi-occlusive dressing). At the end of the contact period excess test substance was washed off.
Observations, examinations: Skin reactions were examined 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches
Data evaluation: Skin reactions were scored according to the table of Draize contained in the OECD TG 404.

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 8 days

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 15 d

Remarks on result:

other: scaling in 2 rabbits

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 15 days

Score:

0.3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: scaling in 3/3 rabbits, erythema score 1 in one rabbit (other score 0)

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1, 24, or 48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 8 days

Irritant / corrosive response data:

The effects extended beyond the area of exposure.

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The undiluted test substance was irritating to the rabbit skin.

Executive summary:

Guideline study

Three New Zealand White rabbits received dermal application 0.5 mL undiluted BVE to the shaved skin under semi-occlusive dressing for 4 h (washing at termination). Scoring was performed 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches. The mean score for erythema was 3.0, 2.7, and 2.7 24, 48, and 72 h after patch removal, respectively. Erythema was not reversible in one rabbit at termination and all three rabbits showed scaling of the skin (day 15). Edema reached only score 1 24 -72 h after patch removal and was reversible within 8 days.

Conclusion: The undiluted test substance was irritating to the rabbit skin.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

adopted 1987

GLP compliance:

yes

Remarks:

(BASF AG, Department of Toxicology)

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: GAUKLER ; OFFENBACH (FRG)
- Age at study initiation: young adults (no further details)
- body weight range at study initiation: 2.76-3.58 kg
- Housing: singly
- certified diet and tap water ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

undiluted
Amount applied: 0.1 mL

Duration of treatment / exposure:

no washing

Observation period (in vivo):

Eye reactions were examined after 1, 24, 48, and 72 h after application

Number of animals or in vitro replicates:

3 (1 male and 2 female)

Details on study design:

0.1 mL of undiluted TS was placed into the conjunctival sack of the rabbit's eye. The substance was not washed out. Effects were scored according to the table of Draize contained in the OECD TG 405. Additionally measured parameters: area of cornea involved and discharge.

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible

Remarks on result:

other: no effects 48 h after application; no effects on iris and cornea at any reading

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 h

Remarks on result:

other: discharge score 1 (max. 3), no effects after 24 h

Irritant / corrosive response data:

No corneal opacity was noted in any of the animals at any reading, i.e. the mean score = 0 for all readings in all animals.
Iritis: no effect in any animal at any time, therefore mean score = 0.
Conjunctivae: mild to moderate reddening, discharge and swelling were noted 1 hour after application but no effects were detected 24 h after application except redness score 1 in one rabbit. No effect was noted at 48 and 72 hrs post treatment (study termination).

Other effects:

no clinical symptoms

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In three White Vienna rabbits the instillation of 0.1 mL of the undiluted test substance into the conjunctival sac of one eye caused reddening (grade 1 - 2) and slight swelling (grade 1) 1 hour after application (no washing). In two rabbits the findings cleared up 24 hours after application or within 48 h in the third rabbit. No effects were noted on cornea or iris.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin Irritation

In a Guideline study 3 New Zealand White rabbits received dermal application 0.5 mL undiluted BVE to the shaved skin under semi-occlusive dressing for 4 h (washing at termination). Scoring was performed 1, 24, 48, and 72 hours and 8 & 15 days after removal of the patches. The mean score for erythema was 3.0, 2.7, and 2.7 24, 48, and 72 h after patch removal, respectively. Erythema was not reversible in one rabbit at termination and all three rabbits showed scaling of the skin (day 15). Edema reached only score 1 24 -72 h after patch removal and was reversible within 8 days (BASF 1997). The undiluted test substance was irritating to the rabbit skin.

Eye Irritation

Aim of the study was the determination of eye irritation effects to New Zealand white rabbits. The study was conducted according to OECD guideline 405. 0.1 mL amount of test item were applied. Eye reactions were examined after 1, 24, 48, and 72 h after application. No corneal opacity was noted in any of the animals at any reading. Conjunctivae: mild to moderate reddening, discharge and swelling were noted 1 hour after application but no effects were detected 24 h after application except redness score 1 in one rabbit. No effect was noted at 48 and 72 hrs post treatment (study termination).

Justification for selection of skin irritation / corrosion endpoint:
GLP study according to guidelines.

Justification for selection of eye irritation endpoint:
GLP study according to guidelines.

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as skin irritating Xi, R38 under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered to be classified as skin irritating categorie 2, H315 under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 605/2014.