1,2-Benzenediol, 3,5-dialkyl-, 1,2-dicarboxylate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 - 16 Nov 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP - Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Ministère de l'Économie, des Finances et de l'Industrie, Secrétariat général du groupe interministériel des produits chimiques, DGCIS, Service de l'industrie, bureau de la chimie, Paris, France

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage JANVIER, Le Genest Saint Isle, France
- Age at study initiation: 7 weeks (males) and 8 weeks (females)
- Weight at study initiation: 221-238 g (males) and 206-217 g (females)
- Housing: rats were housed individually in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contained dust free wood shavings.
- Diet: pelleted diet M20 (SDS), ad libitum
- Water: tap-water from the public distribution system, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

olive oil

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin of the dorsal area of the trunk
- % coverage: 10
- Type of wrap if used: the test material was held in contact with the skin with a gauze dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: the treated areas were rinsed with liquid paraffin.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 10 mL/kg bw
- Concentration: 21.7% (2 g of test material dissolved in 10 mL of olive oil with a density of 0.92 g/mL)
- Constant volume or concentration used: yes

VEHICLE
- Amount applied: 10 mL/kg bw
- Concentration (if solution): 100%

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each animal was weighed on Day 0 (before test substance administration), 2, 7 and 14. Systemic examinations were carried out daily during the 14-day observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights, necropsy included macroscopic examination of animals

Statistics:

For body weights, mean values and standard deviations were calculated for all animals.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

Neither cutaneous reactions nor systemic clinical signs were observed up to the end of the 14-day observation period.

Body weight:

Body weight evolution of the animals remained within the normal ranges in males and females during the whole study period.

Gross pathology:

Macroscopic examination did not reveal substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DSD: not classified