Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across study therefore categorised as Klimisch 2.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
The mixture contains 85% zinc 3,5-bis(α-methylbenzyl)salicylate and 15% PSMS.
Appearance: A whitish, crystalline powder, insoluble in water.


Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Wister rats were used, comprising of 10 per group.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
The test substance was prepared for use by grinding to a fine powder in a mortar and making a suspension in 0.5% Tragacantha solution. The test substance was kept in solution using a magnetic stirrer.
Doses:
0, 500, 1000, 1500, 2000 and 2500 mg/kg body weight.
No. of animals per sex per dose:
10 per group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: No data
- Frequency of weighing: No data
- Necropsy of survivors performed: Autopsy of dead and surviving rats was performed.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 500 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
1 720 mg/kg bw
Based on:
test mat.
95% CL:
1 246 - 2 374
Sex:
male
Dose descriptor:
LD50
Effect level:
2 125 mg/kg bw
Based on:
other: zinc 3,5-bis(α-methylbenzyl)salicylate
Remarks on result:
other: The test material contains 85% zinc 3,5-bis(α-methylbenzyl)salicylate
Sex:
female
Dose descriptor:
LD50
Effect level:
1 462 mg/kg bw
Based on:
other: zinc 3,5-bis(α-methylbenzyl)salicylate
Remarks on result:
other: The test material contains 85% zinc 3,5-bis(α-methylbenzyl)salicylate
Mortality:
Death rate showed a tendency to increase with the passage of time. There was no correlation between dosage level and number of deaths in males.
Male 2500 mg/kg bw: 50% mortality, male 2000 mg/kg bw: 20% mortality, male 1500 mg/kg bw: 40% mortality, male 1000 mg/kg bw: 10% mortality, male 500 mg/kg bw and 0 mg/kg bw: 0% mortality.
Female 2500 mg/kg bw: 60% mortality, female 2000 mg/kg bw: 70% mortality, female 1500 mg/kg bw: 40% mortality.
Clinical signs:
No specific change in condition occurred following administration.
Body weight:
Body weight gain:
Male: 2500 mg/kg bw: 22.7%, 2000 mg/kg bw: 15.3%, 1500 mg/kg bw: 30.3%, 1000 mg/kg bw: 28%, 500 mg/kg bw: 21.4%, 0 mg/kg bw: 38.2%.
Female: 2500 mg/kg bw: 12.8%, 2000 mg/kg bw: 16.0%, 1500 mg/kg bw: 21.5%, 1000 mg/kg bw: 16.5%, 500 mg/kg bw: 13.4%, 0 mg/kg bw: 21.9%.
Gross pathology:
According to the autopsy of dead an surviving animals after 7 days, there were no significant changes, but chalasis of the intestinal tract and a tendency to hypertrophy of the liver were observed.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study, the LD50 was found to be 2500 mg/kg in male Wistar rats and 1720 mg/kg in female Wistar rats for a mixture containing 85% zinc 3,5-bis(alpha-methylbenzyl)salicylate. Therefore, for zinc 3,5-bis(alpha-methylbenzyl)salicylate, the LD50 in male Wistar rats is 2125 mg/kg bw and the LD50 in female Wistar rats is 1462 mg/kg bw based on the test material containing 85% zinc 3,5-bis(alpha-methylbenzyl)salicylate.
Executive summary:

An acute oral toxicity study with a mixture containing 85% zinc 3,5-bis(alpha-methylbenzyl)salicylate, was conducted in male and female Wistar rats.

The death rate showed a tendency to increase with time. There was no correlation between dosage level and number of deaths in males. According to the autopsy of dead and surviving animals after 7 days, there were no significant changes, but chalasis of the intestinal tract and a tendency to hypertrophy of the liver were observed. The LD50 was found to be 2500 mg/kg in male Wistar rats and 1720 mg/kg in female Wistar rats for a mixture containing 85% zinc 3,5-bis(alpha-methylbenzyl)salicylate. Therefore, for zinc 3,5-bis(alpha-methylbenzyl)salicylate, the LD50 in male Wistar rats is 2125 mg/kg bw and the LD50 in female Wistar rats is 1462 mg/kg bw based on the test material containing 85% zinc 3,5-bis(alpha-methylbenzyl)salicylate.

Zinc 3,5-bis(alpha-methylbenzyl)salicylate is therefore classified as Acute Oral Toxicity Category 4 in accordance with the CLP Regulation.