Registration Dossier
Registration Dossier
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EC number: 259-583-7 | CAS number: 55302-96-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No study adressing the fertility endpoint is available for 2-Methyl-5-hydroxyethylaminophenol. However, the results obtained in the 90 days oral repeated dose toxicity study did not show any significant adverse effect on male and female reproductive organs (testes, prostate, seminal vesicles, epididymides, mammary glands, ovaries, uterus and vagina) based on the organ weights, necropsy and micorscopic evaluation findings.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Based on the results of the key study (OECD Guideline 414, GLP, Klimisch 1), the NOAEL oral route (gavage) of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/day (highest dose tested).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Toxicity to reproduction: other studies
Additional information
Toxicity to reproduction:
No study adressing the fertility endpoint is available for 2-Methyl-5-hydroxyethylaminophenol.However, the results obtained in the 90 days oral repeated dose toxicity study did not show any significant adverse effect on male and female reproductive organs (testes, prostate, seminal vesicles, epididymides, mammary glands, ovaries, uterus and vagina) based on the organ weights, necropsy and micorscopic evaluation findings.
Developmental toxicity / teratogenicity:
Two Embryo-foetal developmental toxicity studies by the oral route in the rat are available (one key recent and guideline study with a Klimisch 1 quotation and one non-guideline ancient supporting study with a Klimisch 2 quotation). The results of both studies are concordant. In the key study (OECD Guideline 414, GLP, Klimisch 1), 2-Methyl-5-hydroxyethylaminophenol was administred to female Sprague-Dawley rats by gavage at the doses of 100, 300 and 1000 mg/kg bw from day 6 to 19 of gestation. The results of this study showed that 2-Methyl-5-hydroxyethylaminophenol was well tolerated at all the tested doses, and that no signs of toxicity were noted in the pregnant females, on the embryofetal development or on the growth in utero at any dose-level. Based on the results of this key study, the NOAEL of maternal toxicity and embryo-/foetotoxicity in rats were both 1000 mg/kg bw/day.
Justification for classification or non-classification
The available data do not suggest that 2-Methyl-5-hydroxyethylaminophenol should be classified for reproductive toxicity.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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