Registration Dossier

Administrative data

Description of key information

LD50 (oral, rat): >5000 mg/kg
LD50 (dermal, rabbit): >5000 mg/kg

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pre OECD and pre-GLP study with limited documentation but fulfilling basic scientific principles
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Homosalate was administered orally at a single dose level of 5000 mg/kg bw.
Doses:
5 g/kg bw as single dose
No. of animals per sex per dose:
10 animals were used in this study
Control animals:
no
Details on study design:
The animals were observed for treatment-related effects and gross pathology was performed.
Statistics:
not required
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: only 1 out of ten animals was found dead during observation period
Mortality:
one animal was found dead during observation period (day 6)
Clinical signs:
Animal that died showed signs of diarrhea
Body weight:
no data
Gross pathology:
Necropsy revealed 4/10 animals were normal; yellow areas in the intestines of 1/10 animals; mottled liver in 1/10 animals; dark lungs in 1/10 animals; dark areas in the lungs in 5/10 animals; dark spleen in 1/10 animals.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (oral, rat): > 5000 mg/kg bw
Executive summary:

In this study 10 rats per dose were used (only one dose applied being 5000 mg/kg and therefore no further doses were applied). Animals were observed for mortality and/or systemic effects. Gross necropsy was performed on all animals.

One out of 10 rats died on day 6 of the observation period and thus the LD50 was found being > 5000 mg/kg. No further doses were consequently applied and the study may be considered as limit test accordingly.

Clinical sign observed were diarrhea. 4 out of 10 animals showed no effects upon necropsy. Effects seen in 6 animals were yellow areas in the intestines of 1/10 animals; mottled liver in 1/10 animals; dark lungs in 1/10 animals; dark areas in the lungs in 5/10 animals; dark spleen in 1/10 animals.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pre OECD and pre-GLP study with limited documentation but fulfilling basic scientific principles
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw applied
No. of animals per sex per dose:
10 animals
Control animals:
no
Statistics:
not required
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no deaths occured
Clinical signs:
No clinical signs were observed.
Body weight:
no data
Gross pathology:
Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.
Other findings:
Skin redness slight in 4/10 and moderate in 6/10 animals
Skin edema slight in 7/10 and moderate in 3/10 animals
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (dermal., rabbit): > 5000 mg/kg bw
Executive summary:

In this study 10 rabbits per dose were used (only one dose applied being 5000 mg/kg and therefore no further doses were applied). Animals were observed for mortality and/or systemic effects. Gross necropsy was performed on all animals.

All rabbits survived the study until end and thus the LD50 was found being > 5000 mg/kg. No further doses were consequently applied and the study may be considered as limit test accordingly.

No clinical sign observed. Necropsy revealed 6/10 animals were normal; brown anogenital exudate in 1/10 animals; red areas in the intestines in 1/10 animals; bloated intestines in 1/10 animals; dark liver in 2/10 animals; white nodules in the liver in 2/10 animals.

Slight skin redness was observed in 4 and moderate redness in 6 animals whereas in 7 animals slight edema were noted and moderate edemas in thee remainder.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Homosalate has been investigated in an acute oral toxicity study and an acute dermal toxicity study by O.M. Moreno (MB Research Laboratories, Inc.) and found in both studies having an LD50 > 5000 mg/kg. Thus, no further doses were applied and the study is considered as limit dose study.

Whereas in the oral study using rats diarrhea was observed in one animal that died at day 6 of the observation period, in the dermal study no clinical signs were observed.

Necropsy observations were made in all animals and in the oral study 4 animals out of 10 showed no pathological abnormalities and in the dermal studies 6 out of 10 animals showed no abnormalities. Effects seen at necropsy were rather unspecific including discoloration of intestines, liver and lung tissue and spleen in oral study and discoloration of intestines and liver tissue in the dermal study.


Justification for selection of acute toxicity – oral endpoint
one study available

Justification for selection of acute toxicity – dermal endpoint
one study available

Justification for classification or non-classification

Based on results from an oral and a dermal acute study, both showing LD50 values > 5000 mg/kg, the substance is not classifiable for oral or dermal acute toxicity. No effects were noted requiring Specific Target Organ Toxicity on Single Exposure (STOT SE) and thus the substance is not classifiable according to CLP (Regulation EC No 1272/2008) or DSD (Directive 67/548/EEC) for oral or dermal acute toxicity. Data on inhalative toxicity are not available and not required.