Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc

Molecular formula:

not applicable for UVCB substance

IUPAC Name:

Reaction product of 2-hydroxybenzoic acid, styrene and oxozinc

Test material form:

liquid - solid: mixture of

Remarks:

water and Reaction products of 2-hydroxybenzoic acid and styrene and zinc oxide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable)
- Source: Center of Experimental Animals, AMMS,Beijing
- Weight at study initiation: 180-220 g
- Acclimation period:5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): 40-60%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 cm* 5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed away by soap and clean water
- Time after start of exposure:24 hours

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Clinical signs observation conducted

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occured.

Clinical signs:

other: No toxic signs were observed.

Body weight:

other body weight observations

Remarks:

Body weight increased

Gross pathology:

No pathological changes were observed at necropsy.

Other findings:

- Organ weights:
- Histopathology:
- Potential target organs:
- Other observations:

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute dermal LD50 was larger than 2000 mg/kg bw for both male and female Wistar rats.

Executive summary:

In an acute dermal toxicity study according to OECD TG 402,  10 male and 10 female Wistar rats were exposed to test item at the dose level of 2000 mg/kg bw for 24 hours and afterwards observed for 14 days after removal of the test item.No clinical toxic signs were observed after application of test item and no death occurred with two weeks.No pathological changes were observed at necropsy.Dermal LD 50 was determined as larger than 2000 mg/kg bw for both male and female Wistar rats.