But-3-yn-2-ol

Endpoint summary

Description of key information

The test substance was determined irritating to the skin of rabbits.

The test substance was determined to be corrosive to the eye 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:

April 1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

exposure for 1, 5, 15 min, 20 h, 24 h; shorter observaton period

Principles of method if other than guideline:

Before OECD Guideline 404 was established in 1982, skin irritation was tested using an internal method (BASF test).

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

No further details were provided

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

The test substance was applied in a 55 % solution in water. 0.2 mL/kg bw were used.

Duration of treatment / exposure:

2 animals were treated on different skin areas for 1, 5 and 15 min;
2 animals were treated for 20 h.

Observation period:

8 days

Number of animals:

4

Details on study design:

After the 1, 5 and 15 min or 20 h application the test substance was washed off. First it was washed with Lutol 9 (100 %) and afterwards with Lutrol 9 in water (50 %). Animals were fixated by binding of the animal to an exposure board during application.

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3.5 h

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: animal died

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 3.5 h

Max. score:

4

Remarks on result:

other: animal died

Other effects:

Treatment for 20 h led to the death of the animals during exposure. Animals died 3.5 to 20 h after application.
Pathology revealed an increased fluid accumulation in the thoracic region, starting lungedema and diarrhea.

		24h		48 h		d7
exposure	animal #1	erythema	edema	erythema	edema	erythema	edema
1 ´	#1	-	-	-	-	-	-
	#2	2	-	1	-	-	-
5´	#1	-	-	-	-	-	-
	#2	1	-	1	-	-	-
15´	#1	-	-	-	-	-	-
	#2	1	-	1	-	-	-
20 h	#1	exitus over night
	#2	exitus over night

OECD / Draize Score (max: 4)

Interpretation of results:

Category 2 (irritant) based on GHS criteria

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

Study period:

April 1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

50 µl test substance, no wash-out, shorter observation period

Principles of method if other than guideline:

Before OECD Guideline 405 was established, eye irritation was tested using an internal method (BASF test).

GLP compliance:

no

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

No further details provided

Vehicle:

water

Controls:

other: 0.9 % NaCl solution in other eye of the same animal

Amount / concentration applied:

0.05 mL of 55 % test substance was applied.

Duration of treatment / exposure:

The test substance was applied once and not removed from the eye by washing.

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Max. score:

3

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 1 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1 h

Score:

1

Max. score:

3

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

3

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 24 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks:

within 8 days

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 8 days

Other effects:

Pathology showed a slight hydrothorax, starting lungedema and diarrhea.
After 8 days in both animals scar formation on the treated eye was observed.
The report usually describes findings after 1 and 24 hours, and at the end of the observation period. Thus, for a final evaluation, the findings after 48 and 72 hours from the raw data have to be taken into account.

Interpretation of results:

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

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation/corrosion

Key study

The test substance was applied to the shaved back skin of rabbits (XVII/112, 1967). The animals were exposed for 1, 5 and 15 min, 20 and 24 h. The animals treated not for longer than 15 min survived and were observed for 8 days. The observed effects were reversible. For 1 and 5 min treatment the erythema score for animal 1 was 1 after 24 h for 1 and 5 min treatment and 2 after 24 h for 15 min treatment (max. score 4). For animal 2 the erythema score after 24 h was 0 for all exposure durations. During longer treatment animals died. The death occurred after 3.5 to 20 h after application.

Supporting study

Rabbits were treated with pure and 40 % test substance on the skin (VII/97-98, 1958). After treatment for 5 and 15 min skin reactions, including inflammatory signs and scaling, were observed. Thereby a more severe reaction after treatment with the 40 % solution was revealed in comparison to the pure substance. After 15 min exposure to the pure substance animal 1 had an erythema and edema score of 3 each, while animal 2 had an erythema score of 2 and an edema score of 0. Exposure to 40 % test substance for 15 min resulted in an erythema and edema score for both animals of 3 each. The erythema score for 5 min exposure to 40 % test substance was 3 for animal 1 and 2 for animal 2, while the edema score was 3 for both animals. All observed effects were reversible within 14 days. After 1 and 5 min exposure to the pure substance no erythema and edema where observed in both animals. Application of 40 % substance for 1 min also caused no erythema or edema in the animals. 

Due to the observed effects after only 15 minutes of exposure a classification into category 2 was considered appropriate for safety reasons.

 

Eye irritation/corrosion

Key study

The test substance was applied on the eye of rabbits (XVII/112, 1967). A single drop was used that was not washed out afterwards. The eyes showed reddening, increased secretion, clouding of the eye and scar formation on the cornea. After 24 h the cornea, conjunctivae and chemosis scores were 1 for animal 1. For animal 2 the cornea and conjunctivae scores were 2 and the chemosis score was 1 after 24 h. During an 8 day observation period the effects were not reversible. 

Supporting study

Rabbit eyes were treated with one drop of test substance and observed 10 min, 1, 3 and 24 h afterwards (VII/97-98, 1958). Exposure to both pure and 40 % test substance led to inflammatory responses and corneal opacity with formation of ulcers and scars. No difference was detected between both concentrations, therefore they were considered equally corrosive to the eye. After 24 h the cornea and conjunctivae scores were 3 for animal 1 and 2 for both pure and 40 % test substance. The effects observed in animal 1 were reversible within 4 weeks for the pure substance and within 14 days for the 40 % test substance. For animal 2 all observed effects were not reversible within 3 weeks after application.

As it can not be assured the effects would have been reversible within 21 days the worst case was assumed and the test substance was classified as corrosive to the eye (Category 1).

Justification for classification or non-classification

Skin irritation/corrosion

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 for skin irriation in Category 2. H315: Causes skin irritation.

 

Eye irritation/corrosion

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 corrosive to the eye (Category 1). H318: Causes serious eye damage.