Zinc 3,5-bis(α-methylbenzyl)salicylate

Acute Toxicity: oral

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Mixture containing zinc 3,5-bis(α-methylbenzyl)salicylate

IUPAC Name:

Mixture containing zinc 3,5-bis(α-methylbenzyl)salicylate

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 or test system 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1 720 mg/kg bw

Based on:

test mat.

95% CL:

1 246 - 2 374

Effect levels 3

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

Effect levels 4

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:

other: No specific change in condition occurred following administration.

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.