2-methylundecanal

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

4 rabbits were dermally exposed to the test material for 24 hr and then observed for a further 24 hours for mortality. The first attempt at this experiment was ended early; the study was repeated with 3 new rabbits.

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-methylundecanal

EC Number:

203-765-0

EC Name:

2-methylundecanal

Cas Number:

110-41-8

Molecular formula:

C12H24O

IUPAC Name:

2-methylundecanal

Specific details on test material used for the study:

- Names of test material: RIFM 71-16, aldehyde C-12 MNA
- Substance type: Clear liquid
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.6 to 3.0 kg
- Fasting period before study: No data
- Housing: No data
- Diet: No data
- Water: No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod: No data

Administration / exposure

Type of coverage:

not specified

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap: wrap described as "damming" - no further information.

REMOVAL OF TEST SUBSTANCE
- Washing: Water
- Time after start of exposure: 24 hr

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Constant volume or concentration used: No

Duration of exposure:

24 hr

Doses:

10 mL/kg

No. of animals per sex per dose:

2 male, 2 female (test group 1)
2 male, 1 female (test group 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 10 days (test group 1); 14 days (test group 2)
- Frequency of observations and weighing:
-- Test group 1: Observations every day from days 1-10; weighing on days 0, 3, 7, 10.
-- Test group 2: Observations every day from days 1-14; weighing on days 0, 3, 7, 10, 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: Body weight, skin irritation (erythema, oedema).

Statistics:

No data

Results and discussion

Preliminary study:

No preliminary study

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Based on:

test mat.

Remarks on result:

other: Equivalent to 8280 mg/kg bw when multiplied by density of 828 mg/mL.

Mortality:

No animals died during the study.

Clinical signs:

other: See attached results. Oedema was replaced by a shell of hard peeling skin in rabbits 1A♂ and 1U♂ by day 7 (test group 1) and 8A♂ by day 6 (test group 2).

Gross pathology:

Autopsy revealed no unusual findings.

Other findings:

No data

Any other information on results incl. tables

Please refer to the attached background material.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was assessed for acute dermal toxicity using rabbits. The test material was not acutely toxic to rabbits via the dermal route at a concentration of 10 mL/kg bw.
Multiplying this value by the density value of 828 mg/mL gives a value of 8280 mg/kg bw.