2-methylundecanal

Endpoint summary

Description of key information

The acute oral toxicity of the test substance to rats was studied in a standard acute method.  The LD₅₀ was determined to be >5000 mg/kg bw.
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.
No study is available for acute inhalation toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

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.

Qualifier:

no guideline followed

Principles of method if other than guideline:

10 rats received doses of the test material and were observed for 14 days, then killed and autopsied. Preliminary and main studies were performed.

GLP compliance:

no

Remarks:

Study predates GLP

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

- Names of test material (as cited in study report): RIFM 71-16, aldehyde C-12 MNA
- Substance type: Clear liquid
- Physical state: Liquid

Species:

rat

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: No data
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

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

IN-LIFE DATES: From: To: No data

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION (if unusual): No data

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data

Doses:

Preliminary study - 316 mg/kg, 1260 mg/kg, 5000 mg/kg
Main study - 5000 mg/kg

No. of animals per sex per dose:

Preliminary study - 2 per dose, sex not specified.
Main study - 5 males, 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No data

Statistics:

No data

Preliminary study:

No mortality was observed at doses of 316 mg/kg, 1260 mg/kg or 5000 mg/kg.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died during the study.

Clinical signs:

other: No data

Gross pathology:

Autopsy revealed no unusual findings.

Other findings:

- Organ weights: No data
- Histopathology: No data
- Potential target organs: No data

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity of the test substance to rats was studied in a standard acute method. The LD50 was determined to be >5000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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.

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

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

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

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

Preliminary study:

No preliminary study

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

Please refer to the attached background material.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

8 280 mg/kg bw

Additional information

Acute oral toxicity

The acute oral toxicity of the test substance to rats was studied in a standard acute method on rats. No animals died during the 14-day observation period and autopsies revealed no unusual findings. The LD₅₀ was determined to be >5000 mg/kg bw.

Acute inhalation toxicity

No study is available.

Acute dermal toxicity

The test material was assessed for acute dermal toxicity using rabbits. Dermal irritation was noted. No animals died during the study and autopsy revealed no unusual findings. 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.

Justification for selection of acute toxicity – oral endpoint
The study was performed on the test substance.

Justification for selection of acute toxicity – dermal endpoint
The study was performed on the test substance.

Justification for classification or non-classification

Based on the acute oral LD50 value of 5000 mg/kg body weight and acute dermal LD50 value of 8280 mg/kg body weight, 2 -methylundecanal does not need to be classified for acute toxicity according to the criteria outlined in Annex VI or 67/548/EEC (DSD) and Annex I of 1272/2008/EC (CLP).