Registration Dossier

Administrative data

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:
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 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:
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).