5-[(2-hydroxyethyl)amino]-o-cresol

Endpoint summary

Description of key information

Skin irritation / corrosion: 2-Methyl-5-hydroxyethylamino-phenol is not irritant to rabbit skin when tested undiluted (OECD Guideline 404, GLP, Klimisch 1)

Eye irritation: 2-Methyl-5-hydroxyethylamino-phenol is irritant to rabbit eye when tested undiluted (OECD Guideline 405, GLP, Klimisch 1)

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)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation / corrosion:

Only one study is available for the skin irritation / corrosion endpoint (in vivo study). This key study (OECD guideline 404, GLP, Klimisch 1), in which New Zealand White rabbits were administred undiluted 2-Methyl-5-hydroxyethylaminophenol during 4 hours under semiocclusive dressing, showed no dermal lesions in any animal at any of the observation time points (24, 48 and 72 hours). The individual mean scores (24, 48 and 72 hours) of all three animals for erythema and edema were both: 0.0, 0.0 and 0.0. This study showed that when tested undiluted, 2-methyl-5-hydroxyethylaminophenol was non-irritant to rabbit skin.

Eye irritation:

Two in vivo studies are available for the eye irritation endpoint (one key and one supporting). The key study (OECD guideline 405, GLP, Klimisch 1), in which New Zealand White rabbit eyes were instilled undiluted 2-Methyl-5-hydroxyethylaminophenol without rinsing, showed slight swelling and slight redness of conjunctivae 1 hour after administration. At 24 and 48 hours, animals showed significant swelling with eyelids half or completely closed. At 72 hours, a marked decrease in chemosis was observed. At 24 through 72 hours, significant redness was noted. Grading of the iris was not possible resulting from corneal

opacity. From 1 hour after instillation, corneal translucency was easily identifiable. The cumulative mean indices of chemosis, redness, and cornea were 3.33, 2.00, and 2.33, respectively. This study showed that 2-methyl-5-hydroxyethylaminophenol is an irritant to rabbit eyes when tested undiluted. The supporting study (OECD guideline 405, GLP, Klimisch 1), in which New Zealand White rabbit eyes were instilled 2-Methyl-5-hydroxyethylaminophenol at a concentration of 2% (diluted in a 0.5% carboxymethylcellulose suspension) without rinsing, showed no ocular reactions for any of the three animals treated. This supporting study, showed that a 2% dilution of 2-Methyl-5-hydroxyethylaminophenol was non-irritating to rabbit eyes.

Justification for classification or non-classification

Skin irritation / corrosion:

Based on the available key data, 2-Methyl-5-hydroxyethylaminophenol does not require classification for skin irritation according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.

Eye irritation:

Based on the available key data, 2-Methyl-5-hydroxyethylaminophenol requires a classification for eye irritation as Eye Irritant Category 2 (Eye Irrit. 2, H319) according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) criteria.