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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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).