Reaction mass of undec-8-enal and undec-9-enal and undec-10-enal

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

non-GLP, pre-OECD

Justification for type of information:

The information is used for read across to Intreleven aldehyde.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Reference

Endpoint:

acute toxicity: dermal

Type of 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: The result derived from read across is sufficiently reliable because all Annex XI criteria are met.

Justification for type of information:

The read across justification is presented in the Endpoint summary and the accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

other: Not acute toxic

Remarks:

according to EU CLP criteria (1272/2008/EC and its updates)

Conclusions:

Based on the results of the study for read-across substance Undec-10-enal, an acute dermal LD50 of >5000 mg/kg bw was determined for Intreleven aldehyde.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

1

Reference substance name:

Undec-10-enal

EC Number:

203-973-1

EC Name:

Undec-10-enal

Cas Number:

112-45-8

Molecular formula:

C11H20O

IUPAC Name:

undec-10-enal

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5-3 kg
- Housing: Individually
- Diet (e.g. ad libitum): commercial diet
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 240 cm2
- % coverage: 10% of body surface
- clipped (in half of the animals the skin was lightly abraded)
- Type of wrap: the liquid test material was delivered under a rubber sleeve by using a hypodermic syringe, then the sleeve was covered with Webril padding. The rabbit was fitted with a collar to prevent the removal of the wrapping.

Duration of exposure:

24 hours

Doses:

5 ml/kg bw

No. of animals per sex per dose:

6

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: toxic signs, (local) dermal effects and mortality.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One animal died during the study, no postmortem abnormalities were found.

Clinical signs:

Edema was found in 3/6 animals, Erythema in 5/6. Other dermal reaction occured, such as discoloration (3/6), scaling (3/6), necrosis (1/6) and eschar formation (3/6).

Body weight:

No information.

Gross pathology:

No abnormalities were found.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

other: Not acute toxic

Remarks:

according to EU CLP criteria (1272/2008/EC and its updates)

Conclusions:

Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Undec-10-enal.

Executive summary:

An acute dermal toxicity study was performed according to a method similar to OECD TG 402, as the study was performed non-GLP and pre-OECD (it was rated Klimisch 2). In this study, 6 healthy albino rabbits were dosed dermally with Undec-10-enal at 5000 mg/kg bw. In half of the animals the skin was lightly abraded. The test article was kept in contact with the skin for 24 hours. One rabbits died and five rabbits survived the 5000 mg/kg bw dermal dose. Gross necropsy did not reveal any abnormalities. Clinical signs found were: edema (in 3/6 animals), erythema (in 5/6) and other dermal reactions occurred, such as discoloration (3/6), scaling (3/6), necrosis (1/6) and eschar formation (3/6). Under the conditions of this test, an acute dermal LD50 of >5000 mg/kg bw was determined for Undec-10-enal.