Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane-1,2-diol and glycerol

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study is pre-GLP and pre-OECD guidelines. The study has been performed according to the method of Noakes, D.N. and Sanderson,, D. M: A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26, pp 59-64 (1968). The result of the experiment is considered reliable.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Principles of method if other than guideline:

Pre-guideline study according to Noakes, D.N. and Sanderson,, D. M: A method for determining the dermal toxicity of pesticides. Brit. J. Industr. Med. 26, pp 59-64 (1968). Two doses suspended in 2% CMC were applied to the shaved backs of each 5 male and 5 female rats. Observation period was 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Test material form:

solid - liquid: suspension

Remarks:

migrated information: dispersion

Details on test material:

Test material dispersed in 2% Carboxymethylcellulose
- Physical state: solid, dispersed in 2% CMC

Test animals

Species:

rat

Strain:

other: Tif: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: raised in-house at Ciba-Geigy Ltd. Switzerland, Sisseln
- Weight at study initiation: 180 to 200 grams
- Fasting period before study: no
- Housing: Macrolon cages, individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 55 +/- 5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 14 hours dark / 10 hours light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

2%

Details on dermal exposure:

TEST SITE
- Area of exposure: 60 cm2
- % coverage:
- Type of wrap if used: "dressing fixed with adhesive elastic bandage"

REMOVAL OF TEST SUBSTANCE
- Washing (if done): lukewarm water
- Time after start of exposure: 24 hours

Duration of exposure:

24 hours

Doses:

2150 mg / kg and 3170 mg/kg

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: After 4 hours and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology of organs

Statistics:

no

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 3 170 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no higher doses tested

Mortality:

none

Clinical signs:

Within 4 hours after treatment the rats in all dosage groups showed syspnoea, curved body position and ruffled fur. No local skin irritation was seen.
The animals recovered from systemic symptoms within 10-12 days.

Body weight:

no data

Gross pathology:

No substance-related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD0 is > 3170 mg/kg bw in the rat.

Executive summary:

The substance is practically non-toxic. The dermal LD0 is > 3170 mg/kg bw in the rat.