2-methylbut-3-yn-2-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference 1

Reference Type:

other company data

Title:

Unnamed

Year:

1966

Report date:

1966

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2000

Reference 3

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report - 2-Methylbut-3-yn-ol

Author:

BASF AG

Year:

2002

Bibliographic source:

OECD SIDS

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Internal BASF method was used

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylbut-3-yn-2-ol

EC Number:

204-070-5

EC Name:

2-methylbut-3-yn-2-ol

Cas Number:

115-19-5

Molecular formula:

C5H8O

IUPAC Name:

2-methylbut-3-yn-2-ol

Details on test material:

- Analytical purity: 98.5%

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.00, 2.54 kg

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated other eye of same animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

8 d

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

2

Details on study design:

SCORING SYSTEM: Findings were scored according internal BASF gradings, which could be converted to scoring acc. Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.16

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Any other information on results incl. tables

Irritation scores acc. Draize:

Readings	Animal	Conjunctiva	Chemosis	Corneal opacity	Additional findings
1h	1	2	3	2
	2	2	3	2
3 h	1	2	3	2	dermal ablation
	2	2	3	2	dermal ablation
24 h	1	2	1	2	dermal ablation
	2	2	1	2	bd
48 h	1	2	1	2
	2	2	1	1	bd
72 h	1	2	1	3
	2	2	1	3
6 d	1	2	nd	3	ex
	2	2	1	3
8 d	1	2			st, cv
	2	1		1
Mean 24 - 72 h	1	2	1	2.3
	2	2	1	2
Mean		2	1	2.16

bd: bloody discharge

cv: corneal vascularisation

st: staphyloma

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: EU