Registration Dossier

Administrative data

Description of key information

Skin irritation: slightly irritating (not classified), Key study (OECD 404, Kr. 1)
Eye irritation: irritating in category 2, Key study (OECD 405, Kr. 1)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:

In a dermal irritation study performed according to the OECD guideline No. 404, an in compliance with the GLP, 0.5 mL of undiluted P#620 (purity of 89.01%) was dermally applied on the shaved skin of the dorso-lumbar region of 3 New Zealand White rabbits.Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 4 days for edema and erythema. 

Skin irritation was assessed and scored according to the Draize scale at 30 min, 24, 48 and 72 hrs after the removal of the patch.  

The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 1/1/1 for erythema and 0.3/0.0/0.0 for edema.

Under the test conditions, the test item P#620 induced a slight reversible irritation of the skin but no classification as skin irritant is required according to the Annex VI of the Regulation (EC) No 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EC.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.

Eye irritation:

In an eye irritation study performed according to the OECD No. 405, and in compliance with the GLP, 0.1 mL of undiluted 1-(2-tert-butyl cyclohexyloxy)-2-butanol (P#620) (purity of 89.01%) was instilled into the lower evertid lid of one eye of 3 male New Zealand White Rabbit. After the instillation the substance was not remained. Animals were then observed for 7 days for eye edema (chemosis) and erythema (conjunctivae) of the conjunctive, corneal opacity and iris lesion. 

Eye irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hrs after the instillation of the substance. The mean individual scores were calculated within 3 scoring times (24, 48 and 72 hrs).

The mean individual scores were 0.3/0.7/0.0 for chemosis, 1.3/1/1 for conjunctival erythema, 1/1.7/1 for corneal opacity and 0.0/0.0/0.0 for iris lesion. These observed effects were all reversible within 7 days.

Under the test conditions, the test item P#620 induced a reversible eye irritation, with a mean score for cornea opacity ≥1 for at least 2/3 animals. The test item is therefore classified as irritating to eyes in Category 2 (H319, Causes serious eye irritation) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) but is not classified for eye irritation according to the criteria of the Annex VI of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Harmonized classification:

The test item has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including the ATP2 draft.

Self-classification:

Based on the available data, 1-(2-tert-butyl cyclohexyloxy)-2-butanol (P#620) is not classified for skin irritation according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) and to the criteria of the Annex VI of the Directive 67/548/EC.

1-(2-tert-butyl cyclohexyloxy)-2-butanol (P#620) is self-classified for eye irritation:

- in Category 2 (H319, Causes serious eye irritation) according to the criteria of the Regulation (EC) No 1272/2008 (CLP) since corneal opacity is ≥1 for at least 2/3 animals,

- not classified for eye irritation according to the criteria of the Annex VI to the Directive 67/548/EEC.