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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reference
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

No additional information

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.

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
Reference
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

No additional results

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.

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.