Reaction mass of tridecanal and 2-methyldodecanal and pentadecanal and 2-methyltetradecanal

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guidelines. Read-across hypothesis: for details please see read-across report in IUCLID section 13

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

1961

Report date:

1961

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Final Order, Enforcement Regulations (Fed. Register of August 12, 1961, Vol 26, No. 155, pages 7333-7341)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Undecanal

EC Number:

203-972-6

EC Name:

Undecanal

Cas Number:

112-44-7

Molecular formula:

C11H22O

IUPAC Name:

undecanal

Test animals

Species:

rabbit

Strain:

other: albino

Sex:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2500 to 3500 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 10.7% of body surface
- Type of wrap if used: made of rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing: after removal of sleeves by thorough wiping
- Time after start of exposure: up to 24 h

Duration of exposure:

up to 24 h

Doses:

5000 mg/kg

No. of animals per sex per dose:

6 (3 animals with intact skin, 3 animals with abraded skin)

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days

Results and discussion

Effect levels

Effect levels 1

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no animals died within the 14 days observation period

Effect levels 2

Sex:

not specified

Dose descriptor:

LD0

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Mortality:

no deaths occurred

Clinical signs:

other: dry and cracked skin noted

Gross pathology:

no data

Any other information on results incl. tables

Read-across justification: for details please see read-across report in IUCLID section 13

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP Regulation

Conclusions:

Under the tested conditions, the substance did not reveal acute dermal toxicity.

Executive summary:

The test item (purity: not stated) was subjected to test acute dermal toxicity in albino rabbits. This study was conducted according to the requirements of Federal Register, 1961 (Vol 26, No. 155, pages 7333 -7341). The undiluted substance was applied at a limit dose of 5000 mg/kg bw onto the intact or abraded skin of the animals (3 animals per condition) for up to 24 h under occlusive conditions.

During the 14 days observation period dry and cracked skin could be noted, but no animal died. The given results lead to a LD50 > 5000 mg test item per kg bw (LD0 = 5000 mg/kg bw; Shelanski and Moldovan, 1971).

This study was judged to be reliable with restrictions (RL2), due to missing information on substance purity and the missing necropsy data.