Registration Dossier
Registration Dossier
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EC number: 259-583-7 | CAS number: 55302-96-0
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity:
Oral (gavage): NOAEL-90 days in the male and female rat = 220 mg/kg bw/day based on clinical signs, body weight and weight gain and urinalysis (OECD Guideline 408, GLP, Klimisch 1).
Dermal: no study available.
Inhalation: no study available.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 220 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity- Oral (gavage):
Two studies in the rat are available for the Repeated dose toxicity (oral route) endpoint: one 14 days range finding study (flagged as supporting) perfomed to determine the doses to be used in the main study and one 90 days toxicity study (the main study). In the 90 days repeated toxicity key study (OECD guideline 408, GLP, Klimisch 1), male and female Sprague-Dawley rats reveived 2-Methyl-5-hydroxyethylamino-phenol daily at doses of 50, 220 and 1000 mg/kg bw/day by gavage for 13 weeks. The results of this study showed that the substance induced at all dose levels findings in relationship with the staining properties of the test substance. The 50 and 220 mg/kg/day dose levels did not show signs of toxicity. At 1000 mg/ kg/day were noted mainly ptyalism in all animals, loud breathing, a very slightly lower (not statistically significant) body weight gain (females) and a higher incidence of proteinuria. Based on the results of the key study, the NOAEL of oral subchronic toxicity in rats for
2-Methyl-5-hydroxyethylamino-phenol is 220 mg/kg bw.
No data are available for the dermal and inhalation routes.
Justification for classification or non-classification
Based on the available key study, there are no data to suggest that 2-Methyl-5-hydroxyethylamino-phenol should be classified for STOT-RE following oral exposure.
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