Registration Dossier

Administrative data

Description of key information

Based on availble studies, Guetol is:
- very slightly irritating for the skin.
- severely irritating for the eyes.

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:

Only one study was available, selected as key study, with reliability 1 according to Klimisch cotetion criteria.

The summary of this study is the following:

In a study (CIT 2003),the potential of the test item Guetol to induce skin irritation was evaluated in rabbits according to OECD 404 guideline.

A single dose of 0.5 mL of the undiluted test item was applied to the closely-clipped skin of one flank.

The test item was held in contact with the skin by means of a semi-occlusive dressing.

Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.

The mean values of the scores for erythema and oedema were calculated for each animal.

After a 4-hour exposure (three animals), a well-defined erythema was noted in 2/3 animals on day1. Avery slight erythema persisted in one of them up to day 3.

Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.7 for erythema and 0.0, 0.0 and 0.0 for oedema.

Based on these results, the test item Guetol is very slightly irritant when applied topically to rabbits but not warranting classification according to EU GHS (CLP 1272/2008).

Eye irritation:

Only one study was available, selected as key study, with reliability 1 according to Klimisch cotetion criteria.

The summary of this study is the following:

In a study (CIT, 2003), the potential of the test item Guetol to induce ocular irritation was evaluated in one rabbit according to OECD 405 guideline.

A single dose of 0.1 mL of the undiluted test item was instilled into the left conjunctival sac.

The right eye was not treated and served as control.

The eyes were not rinsed after administration of the test item, but were rinsed on days 2 and 3,

for 30 seconds, using sterile isotonic saline solution (0.9% NaCl).

Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until day 6 (sacrifice).

The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated.

Severe conjunctival reactions (severe chemosis, moderate redness of the conjunctiva and whitish purulent discharge) were observed from day1. Aslight iritis and a slight corneal opacity were also noted from day 2.

Therefore, as severe ocular reactions were observed from day 1 and as poor clinical conditions were noted from day 3 up to day 6, the animal was killed on day 6 for ethical reasons.

Mean scores calculated for the animal over 24, 48 and 72 hours were 4.0 for chemosis, 3.0 for redness of the conjunctiva, 1.0 for iris lesions and 2.0 for corneal opacity.

 

Based on these results, the test item Guetol is considered as severely irritant when administered by ocular route to rabbits, warranting classification asEye irr Cat. 1 "Causes serious eye damages", according to EU GHS (CLP 1272/2008).


Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: highly irritating

Justification for classification or non-classification

Based on available data, and EU classification criteria, guetol is not classified for skin irritation.

Based on severe cunjunctival reactions with absence of reversibility over 6 days post instillation and the fact that animal was killed for ethical reasons, guetol should be classified as "severely irritating to the eyes" (or "causes serious eye damage" Cat. 1 (H318)), based on the criteria of Annex VI Directive 67/548/EC (or UN/EU GHS, respectively).