Registration Dossier

Administrative data

Description of key information

Irritating to the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin

Six rabbits were exposed to 0.5 ml and isotridecanol, neat, for 4 hours to evaluate the skin irritation potential.  Irritation responses were examined at 1, 24, 48, and 72 hours and 7 days post exposure.  Very slight to well-defined erythema was noted at all treated skin sites one and 24 hours after patch removal with very slight erythema at the 48 and 72-hour observations.  The erythema extended up to 6 cm beyond all treatment sites during this time.  Very slight edema was noted at all treated skin sites one and 24 hours after patch removal.  Very slight edema was noted at three treated skin sites at the 48 hours observation and persisted at one treated skin site at the 72-hour observation.  Desquamation extending up to a 6 cm beyond the treatment site was noted at two treated skin sites at the 48-hour observation, at five treated skin sites at the 72 hour observation and at all treated skin sites 7 days post exposure.   The mean skin irritation scores between 24 and 72 hours were: erythema 1.1 and edema 0.5. Greater emphasis is placed on this study due to the larger number of animals tested as compared to the second study described.

 

In a second study, isotridecanol was evaluated for the potential to induce skin irritation in the rabbits.  Six rabbits were exposed via a semi-occlusive wrap.  Three rabbits had their skin abraded and 3 had intact skin.  In the area of application no staining of the treated skin by pigment or coloring of the test material was observed.  No destructions or irreversible alterations of the skin were observed.  No corrosive effect had occurred on the skin at any measuring interval.  Slight erythema was noted in all animals, but these effects were resolved within 7 days of exposure. The mean skin irritation scores between 24 and 72 hours were: erythema 2 and edema 0.11 for animals with intact skin. Scaling was moderate in 2 animals and slight in 1 animal by 7 days.

 

Eye

Isotridecanol was evaluated for its eye irritation potential in rabbits.  0.1 ml was instilled into the left eye of 6 rabbits.  Thirty seconds after instillation, 3 of the 6 rabbits had their eyes rinsed clear of the test material.  All rabbits were examined at 1, 24, 48 and 72 hours and 7 and 14 days post exposure.  No staining of the corneas and conjunctivae was observed in the rabbits during the entire test period which could be related to the test article effects.  No corrosion effect was observed at each of the measuring intervals.  No acute toxicological signs were observed in the animals during the test.  The signs of slight irritation that were noted in the 3 rabbits of the un-rinsed group were typically resolved by the 7 day observation period.  The eye irritation potential for isotridecanol is minimal. Mean eye irritation scores between 24 and 72 hours were: cornea score 1, iris score 0.33, conjunctival redness 1.22, and chemosis 0.33.

 

In a second study, a single application of 0.1 ml of isotridecyl alcohol was administered undiluted to the eyes of rabbits to assess eye irritation potential.  In five animals, a slight degree of irritation which completely subsided by the second or third day post exposure was noted.  A sixth animal had symptoms resolved within 7 days post exposure.  There was no sign of corneal damage. The eye irritation potential for isotridecanol is minimal. Mean eye irritation scores between 24 and 72 hours were: cornea score 1, iris score 0.03, conjunctival redness 0.8, and chemosis 0.08.

Justification for classification or non-classification

Skin

The data for the substance identified by CAS number 68526-86-3, subject of this registration, was demonstrated in a well-documented GLP study conducted according to recognized testing methodologies to produce skin irritation. This assessment is based on desquamation noted in all 6 animals at Day 7 in one study, and slight to moderate scaling in all 3 animals at Day 7 in another study.

Isotridecanol CAS number 68526-86-3 is therefore classified as irritant to skin according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) and the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.

No classification for eye irritation is indicated according to the general classification and labeling requirements for dangerous substances and preparations (Directive 67-548-EEC) or the classification, labeling and packaging (CLP) regulation (EC) No 1272/2008.