3-methylbut-3-en-1-ol

Endpoint summary

Description of key information

SKIN IRRITATION:
not irritating to the skin (BASF, 1968)
EYE IRRITATION:
risk of serious damage to the eyes (BASF, 1968)
RESPIRATORY IRRITATION:
No data are available.

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:

1968-09-24

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

Before OECD Guideline 404 was established in 1984, skin irritation was tested using an internal method (BASF Test); the procedure of which is similar to OECD TG 404.

GLP compliance:

no

Remarks:

pre-GLP study

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

No further data.

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites of the same animals

Duration of treatment / exposure:

1, 5, and 15 minutes (short-term test);
20 hours (long-term test)

Number of animals:

2 (short-term test);
2 (long-term test):
totally 4 animals

Details on study design:

TEST SITE
- Area of exposure: back (short-term test and long term test); inner auricle (long-term test); see freetext

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water, possibly containing a mild detergent
- Time after start of exposure: at the end of the respective exposure period

SCORING SYSTEM:
BASF scoring system, convertible to Draize system

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 8 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 8d

Score:

0

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

24-hour reading:
In one animal, questionable redness was observed at the dorsal skin that had been treated with the test substance for one minute; no signs of irritation were noted at the respective skin site of the other animal. Questionable and slight redness was observed at the dorsal areas treated for 5 minutes and longer in one animal each. Slight redness was noted at the auricular skin of both animals.

8-day reading:
No signs of irritation were observed at any skin site.

Table:  Skin findings and scores (converted to Draize system)

 

Application site	Exposure time	Findings at 24 h		Findings at 8 d
		Animal no. 1	Animal no. 2	Animal no. 1	Animal no. 2
Back	1 min 5 min 15 min	Erythema: 0 Erythema: 1 Erythema: 1	No findings Erythema: 0 Erythema: 0	No findings at any treated site	No findings at any treated site
Back	20 h	Erythema: 1	Erythema: 0
Ear	20 n	Erythema: 1	Erythema: 1

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The test substance was not a primary skin irritant under the conditions of this test.

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:

1968-10-14 to 1968-10-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment; pre-GLP study.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

Before OECD Guideline 405 was established in 1984, skin irritation was tested using an internal method (BASF Test); the procedure of which is similar to OECD TG 405.

GLP compliance:

no

Remarks:

pre-GLP study

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
2 male Vienna White rabbits
- Weight at study initiation: 2.65 kg (animal #1), 2.87 kg (animal #2)
- Weight at study termination: 2.74 kg (animal #1), 2.9 kg (animal #2)
No further data

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Vehicle:

unchanged (no vehicle)

Controls:

other: saline-treated adjacent eye of test animals

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.05 ml

Duration of treatment / exposure:

instillation without rinsing

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
BASF scoring system, convertible to Draize system

Irritation parameter:

cornea opacity score

Basis:

other: 2 animals

Time point:

other: 1 h

Score:

ca. 3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

other: 2 animals

Time point:

24 h

Score:

ca. 3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

other: 2 animals

Time point:

other: 8 days

Score:

ca. 3

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

iris score

Basis:

other: 2 animals

Time point:

other: 1h - 8 days

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

other: 2 animals

Time point:

other: 1h

Score:

ca. 2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

other: 2 animals

Time point:

24 h

Score:

1

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

conjunctivae score

Basis:

other: 2 animals

Time point:

other: 8 days

Score:

ca. 2

Max. score:

3

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

other: 2 animals

Time point:

other: 1 h

Score:

ca. 3 - ca. 4

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

other: 2 animals

Time point:

24 h

Score:

ca. 1 - 2

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

chemosis score

Basis:

other: 2 animals

Time point:

other: 8 days

Score:

ca. 1

Max. score:

4

Reversibility:

not reversible

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

chemosis score

Basis:

mean

Time point:

72 h

Remarks on result:

not measured/tested

Irritant / corrosive response data:

1-hour reading:
strong conjunctival redness, very strong edema (chemosis), strong corneal  opacity, brown colouration of the mucosa

24-hour reading:
slight conjunctival redness, strong edema (chemosis), strong corneal  opacity, brown colouration of the mucosa

8-day reading: strong conjunctival redness, slight edema (chemosis), moderate corneal  opacity, vascularization, staphyloma

Saline control:
No signs of irritation were observed at any reading.

Other effects:

No significant change in body weight was observed for the two animals.

Table:  Findings and scores (converted to Draize system)

 

Reading	Eye	Animal No.	Corneal opacity	Iris	Conjunctival redness	Chemosis	Other findings
1 h	Treated	1 2	3 3	0 0	2 2	2 3-4	brown colouration of the mucosa brown colouration of the mucosa
	Control	1 2	No findings
24 h	Treated	1 2	3 3	0 0	1 1	1 2	bleeding and brown colouration of the mucosa bleeding and brown colouration of the mucosa
	Control	1 2	No findings
8 d	Treated	1 2	3 3	0 2	2 2	1 1	mucosal bleeding, vascularization, staphyloma mucosal bleeding, vascularization, staphyloma
	Control	1 2	No findings

 

Interpretation of results:

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

Remarks:

Migrated information

Conclusions:

The test substance implies the risk of serious damage to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

SKIN IRRITATION

In a primary dermal irritation study (BASF, 1968), 2 Vienna White rabbits were dermally exposed to unchanged 3-methyl-3-buten-1-ol (99% pure) for 1, 5, and 15 minutes. Two further Vienna White rabbits were dermally exposed to 3-methyl-3-buten-1-ol (99% pure) for 20 hours. All applications were made under occlusive conditions to a dorsal skin area of 2.5 cm x 2.5 cm in size. Animals then were observed for 8 days. Irritation was scored by an internal method; the scores are convertible to Draize scores.

Signs of irritation were limited to slight erythema (Draize score 1) observed at 24 h at each site with exception of the dorsal site exposed for one minute. All test sites were normal by day 8. In this study, 3-methyl-3-buten1-ol is minimally irritating to the skin; labeling is not required.

EYE IRRITATION

In a primary eye irritation study (BASF, 1968), 50 µl of unchanged 3-methyl-3-buten-1-ol (99% pure) was instilled into the conjunctival sac of the right eye of 2 Vienna White rabbits without rinsing. For control purpose, saline was instilled into the left eye of each rabbit. Animals then were observed for 8 days. Irritation was scored by an internal method; the scores are convertible to Draize scores.

Marked to strong corneal opacity, conjunctivae redness, chemosis, and iritis, were reported and persisted at the end of the 8-day observation. Furthermore, mucosal bleeding and vascularization were observed. In this study, 3-methyl-3-buten-1ol is severely irritating to the eye based on persisting corneal opacity and iritis.

 

RESPIRATORY IRRITATION

No data are available.

Effects on eye irritation: corrosive

Justification for classification or non-classification

There is no need to classify 3-methyl-3-buten-1-ol for skin irritation according to the Directive 67/548/EC or GHS criteria.

Based on persisting corneal opacity and iritis observed at 8 days after instillation, 3-methyl-3-buten-1-ol has to be classified as “risk of serious damage to the eyes” according to the Directive 67/548/EC. According to the GHS criteria, 3 -methyl-3 -buten-1 -ol has to be classified as follows: Cat. 1 (irreversible effects on the eye).