Registration Dossier

Administrative data

Description of key information

Irritation:
skin: not irritating (rabbit, 20h)
eye: irreversible damage (rabbit)

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Internal BASF method was used, which was in large part equivalent to methods described in OECD Guideline 404
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.9, 2.78 kg
Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: other side of same animal, treated with saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
1 min, 5 min, 15 min, 20 h
Observation period:
5 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of back skin
- Type of wrap if used: cotton pad (seize: 2.5 cm x 2.5 cm) saturated with the undiluted test substance (ca. 0.5 ml)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 50% Lutrol (polyethylenglycol) dilution in water
- Time after start of exposure: 1, 5, 15 min and 20 h


SCORING SYSTEM:
Erythema and edema were scored according the below described system:
Although the results in the report were originally not given as Draize scores the data can be transferred into the Draize scoring system (in brackets). (+) = none - negligible effect (0)
+ = slight effect (1)
++ = moderate effect (2)
+++ = severe effect (>= 3)
N = necrosis
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: after 20 h application
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: after 20 h application

Irritation scores acc. Draize::

Readings Animal Exposure period: 1 min Exposure period: 5 min Exposure period: 15 min Exposure period: 20 h
Erythema Edema Additional findings Erythema Edema Additional findings Erythema Edema Additional findings Erythema Edema Additional findings
1h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
24 h 1 0 0   0 0   0 0   2 0 overlapping  test site
2 0 0   0 0   0 0   0 0  
48 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
72 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
96 h 1 0 0   0 0   0 0   0 0  
2 0 0   0 0   0 0   0 0  
Mean 24 - 72 h 1 0.0 0   0.0 0   0.0 0   0.7 0  
2 0.0 0   0.0 0   0.0 0   0.0 0  
Mean   0 0   0 0   0 0   0.3 0  
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Reason / purpose:
reference to same study
Qualifier:
no guideline followed
Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no
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
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
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2.16
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
1
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible

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

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Irritation to skin was assessed in a study which was in large part similar to OECD guideline 404 (BASF, 1966). Two Vienna White rabbits were patched with ca. 0.5 ml of 2-methylbut-3-yn-2-ol under occlusive conditions for 1, 5, 15 minutes and 20 hours. After the application period, the site was washed with the mild detergent 50% Lutrol in water and observed for five days. As result no irritation was found, as the resulting erythema and edema sores were 0.3 and 0 after the longest exposure period.

In addition, a study with human was available where six subjects received a patch application for 24 hours followed by a twelve days postexposure period (I.G. W.-Elberfeld, 1940). As result, one subject showed slight erythema which disappeared on day two. However, this result could not clearly be referred to the substance due to the low concentration (70%) and contaminants (5%) in the test solution.

In contrast, 2-methylbut-3-yn-2-ol was found to be severe irritant to eyes, when 50 µl were instilled into the eyes of two Vienna White rabbits (BASF, 1966). The found evaluation scores for corneal opacity, chemosis and conjunctival erythema were 2.16, 1 and 2, respectively. Thereby, the observed effects including staphyloma formation were not reversible within the eight day observation period.

In addition, a severe effect was also reported in a Russian study where no detailed information was given (Balynina, 1987).

Justification for classification or non-classification

Classification is not warranted concerning skin irritation according to the criteria of Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008. However, classification as bearing risk of serious damage to eyes is required (GHS cat .1).