Esterification products of alkenylsuccinic anhydride and 2-dialkylaminoethanol

Acute Toxicity: dermal

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Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25th May 1993 to 8th June 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1100 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2518 to 2793 grams
- Housing: Individual suspended mesh-bottom cages
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 °C
- Humidity (%): 50-82 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back
- % coverage: 20 %
- Type of wrap if used: Doses were applied under gauze binders that were secured with tape. Collars were applied and remained on the animals for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped with wet disposable paper towels moistened with mineral oil (USP).
- Time after start of exposure: At the end of the exposure period

TEST MATERIAL
- Amount(s) applied: 2.13 mL/kg
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and clinical effects at 1, 3 and 4 hours post dosing on day 0, thereafter animals were observed twice daily (morning and afternoon) for mortality and once daily for clinical observations for the rest of the 14 day observation period. Body weights were measured on days 0, 7 and 14. Dermal observations were performed 30-60 minutes after bandage removal and daily thereafter. The animals were shaved and days 3, 7, 10 and 14 to facilitate observations.
- Necropsy of survivors performed: yes

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:

There were no unscheduled deaths during the study.

Clinical signs:

Vocalisation after handling was noted in one femal of day 2. One female had dried red material around the mouth on day 0 that was considered to be related to the restraining collar. There were no other clinical findings during the study.

Body weight:

There were no remarkable changes or differences in body weights during the study.

Gross pathology:

An accessory spleen was noted for two rabbits terminally necropsied. This is a common congenital abnormality. There were no other gross necropsy findings.

Other findings:

The test material induced moderate to severe erythema and oedema in all rabbits. All sites had desquamation initially on day 4-5. Nine rabbits were hypersensitive to site manipulation during the dirst week of the study. Eschar and subsequent exfoliation were present on six sites by day 7. Fissuring was noted sporadically during the first week of the study for six sites. All sites had very slight to slight erythema and/or oedema and desquamation at study termination (day 14). There were no other dermal findings.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the test, the LD50 of the test material in male and female rabbits was determined to be greater than 2000 mg/kg bw.

Executive summary:

The acute dermal toxicity of the test material was examined in male and female rabbits in a study conducted in accordance with OECD 402, EU Method B.3 and EPA OTS 798.1100. Under the conditions of the test, the LD50 of the test material in male and female rabbits was determined to be greater than 2000 mg/kg bw.