Registration Dossier

Administrative data

Description of key information

Valid data for the skin and eye irritation potential of triclosan are available. The following main studies, i.e. key studies, were retained for assessment of skin and eye irritation.
For skin, a Draize test with rabbit was conducted, according to the method of US Association of Food and Drug Officials: "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959), (Ciba-Geigy Ltd Siss4719). Based on the results and scorings obtained and taking the test conditions into account, triclosan was found to be irritating to the skin of rabbit.
For eye, a rabbit study conducted according to US EPA Guideline Proposal §163.81-4 which is similar to OECD 405 is available Ciba-Geigy Ltd 801012.). Under the test conditions used, the application of the unchanged test item in the eyes of rabbits revealed that the triclosan substance is irritant to the eye of rabbit; in 2 of 6 animals, effects still were seen after an observation period of 7 days.

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

For skin irritation testing, a gauze patch of 2.5 x 2.5 cm soaked with the test item was applied for 24 hours to the prepared abraded and non abraded skin of 6 rabbits, under occlusive conditions (Ciba-Geigy Ltd Siss 4719). The Draize scoring system was used for evaluation of the skin reactions at 0 and 48 h post exposure, unfortunately the observation period was not extended to clarify the reversibility of all effects. Only the findings referring to the intact skin were considered for assessment of the irritant potential of the test item. The mean erythema score (time point 24 and 48 hours) in 4 of 6 animals was ≥ 2; for the 2 remaining animals the means were 1 and 1.5, respectively. The mean edema score (time point 24 and 48 hours) was ≥ 1 in 4/6 case, reaching a value of 2 in one animal; for the remaining animals the score was 0.5. The scores indicate that under the test conditions used, triclosan was irritating to the skin of rabbit. For eye irritation testing, triclosan (0.1 g) was instilled into the conjunctival sac of the left eye of each test animal (Ciba-Geigy Ltd 801012). The treated eyes were not rinsed. Ocular reactions were scored at 24, 48 and 72 h, and 4 and 7 days after test substance administration. The results were assessed according the Draize. Triclosan produced moderate irritation characterized by corneal and iridial involvement and conjunctival irritation. Triclosan produced irritation characterized by corneal and iridial involvement and conjunctival irritation. The average score of the 24, 48, and 72-h observations for animals ranged from 0.66 to 2.33 for conjunctival redness, from 0.66 to 2.33 for chemosis, from 0.33 to 1 for corneal opacity and from 0 to 1 for iritis. Non reversibility of findings after 7 days was observed in some cases.


Effects on eye irritation: corrosive

Justification for classification or non-classification

In the current (29th) ATP of Annex I to Directive 67/548/EEC, triclosan is classified with R36/38. The results of the available skin study support the R38 classification.

For eye irritation, since non reversibility of findings after 7 days was observed in some cases, one criterion for assigning R41 according to the EU Directive 67/548/EEC is met. However, since the OECD 405 recommends an extended period of observation up to 21 days post instillation, it is likely that the findings seen after 7 days would have fully recovered by this time. In the current (29th) ATP of Annex I to Directive 67/548/EEC, triclosan is classified with R36, it is therefore proposed to adopt this current classification.

 

According to the Annex VI of the CLP regulation, triclosan does not have to be classified for skin irritation and has to be classified Category 2 for eye irritation