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EC number: 228-408-6 | CAS number: 6259-76-3
Endpoint summary
Administrative data
Description of key information
A rat acute oral toxicity study and a rabbit acute dermal toxicity study are available. The older, proprietary studies were also published in a review of available toxicological data relating to several salicylates used as fragrance ingredients.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- predates GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Doses:
- 5 g/kg
- No. of animals per sex per dose:
- 10 animals/dose
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- Not required
- Preliminary study:
- Not relevant
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1/10 rats died
- Clinical signs:
- other: Urinary incontinence was observed at 24 hours
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 in rats was greater than 5000 mg/kg bw
- Executive summary:
The acute oral LD50 of hexyl salicylate in rats was found to greater than 5000 mg/kg bw, under the conditions of this study. One of 10 rats died; signs of toxicity were imited to urinary incontinence at 24 hours after dosing.
Reference
No additional information
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Older proprietary study, supported by data from a published review.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Incomplete report, only results available.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- predates GLP
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 animals
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- No data
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed
- Clinical signs:
- other: 2 rabbits demonstrated slight redness. 8 rabbits demonstrated moderate redness. 3 rabbits demonstrated slight oedema. 7 rabbits demonstrated moderate oedema.
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of hexyl salicylate in rabbits was found to be greater than 5000 mg/kg bw under the conditions of this study.
- Executive summary:
The dermal LD50 of hexyl salicylate in rabbits was found to be greater than 5000 mg/kg bw under the conditions of this study. No deaths occurred and there were no signs of toxicity. Local irritation was observed at the application site.
Reference
No additional results
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- Older proprietary study, supported by data from a published review.
Additional information
Moreno (1975) reports an acute oral LD50 of 5000 mg/kg bw for hexyl salicylate in the rat; this value is also reported in a published review (Belsito, 2007).
Moreno (1975) reports an acute dermal LD50 of 5000 mg/kg bw for hexyl salicylate in the rabbit; this value is also reported in a published review (Belsito, 2007).
Justification for classification or non-classification
Hexyl salicylate is of low acute oral and dermal toxicity; acute inhalation toxicity are not available. Based on the available data, classification for acute toxicity according to Regulation (EC) No 1272/2008 is not required.
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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