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

Endpoint summary

Description of key information

Oral (gavage): LD0: > 2,000 mg/kg for female rat (limit test; OECD Guideline 420, GLP, Klimisch 1)

Dermal: LD50: > 2,000 mg/kg for male and female rat (limit test; OECD Guideline 402, GLP, Klimisch 1)

Inhalation: no study available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Acute oral toxicity:

The one key acute oral toxicity study (OECD guideline 420 -limit test, GLP, Klimisch 1), in which Sprague-Dawley female rats were given a single gavage dose (2000 mg/kg bw) of 2-Methyl-5-hydroxyethylaminophenol, gave a maximum non-lethal dose higher than 2000 mg/kg bw. Hypoactivity or sedation, piloerection and dyspnea were observed in all animals on day 1 within the 2 hours following the treatment. No clinical signs were observed thereafter on day 1 but from day 2 up to day 5 and then on days 14 and 15, noisy breathing was observed in 1/4 animals. This clinical sign was associated with piloerection and swollen abdomen on days 14 and 15. A body weight loss was seen in 1/4 females between days 1 and 15. The overall body weight gain of the other animals was similar to that of testing laboratory historical control animals. Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Acute dermal toxicity:

The one key acute dermal toxicity study (OECD guideline 402 -limit test, GLP, Klimisch 1) in which male and female Sprague-Dawley rats were administered a single dose (2000 mg/kg bw) of 2-Methyl-5-hydroxyethylamino-phenol for 24 hours under semiocclusive coverage, gave an LD50 value > 2000 mg/kg bw. No deaths and no clinical signs were observed during the study. An orange coloration of the skin was observed in all animals from day 2 until day 6 (1/5 males), day 10 (another male) or day 15 (3/5 males and 5/5 females). An erythema was noted in 2/10 animals on day 2; it persisted in one of them until day 6. A dryness of the skin was noted in 1/10 animals from day 3 until day 6. Crusts were observed in 3/10 animals from day 7 until day 10 (2/3 animals) or day 15 (1/3 animals).

When compared to the testing laboratory historical control animals, a slightly lower body weight gainnwas noted in 1/5 males and 1/5 females between day 1 and day 8; it returned to normal thereafter. The

body weight gain of the other animals was not affected by treatment with the test item. No apparent abnormalities were observed at necropsy in any animal.

Acute inhalation toxicity:

According to column 2 in the table given in REACH Annex VIII, acute inhalation toxicity, "Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size." According to Chapter R.7a: Endpoint specific guidance (Version 5.0 - December 2016) (pages 356 -357), a waiving should be considered for 2-Methyl-5-hydroxyethylaminophenol as the inhalation route is not relevant for this substance.

Justification for classification or non-classification

There are no existing or proposed classifications for the acute toxicity of 2-Methyl-5-hydroxyethylaminophenol.

Acute oral toxicity:

Based on the results of the one key study (OECD guideline 420 -limit test, GLP, Klimisch 1) giving an LD0 > 2000 mg/kg bw in the rat, 2-Methyl-5-hydroxyethylaminophenol is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria.

Acute dermal toxicity:

Based on the results of the one key study (OECD guideline 402 -limit test, GLP, Klimisch 1) giving an LD50 > 2000 mg/kg bw in the rat without mortality, clinical signs or macroscopic findings, 2-Methyl-5-hydroxyethylaminophenol is not classified as hazardous for acute dermal toxicity 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.