Registration Dossier

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:
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 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:
Urinary incontinence was observed at 24 hours
Body weight:
No data
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
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:
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 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:
2 rabbits demonstrated slight redness.
8 rabbits demonstrated moderate redness.
3 rabbits demonstrated slight oedema.
7 rabbits demonstrated moderate oedema.
Body weight:
No data
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
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.