Decene, hydroformylation products, low boiling

Endpoint summary

Description of key information

The available acute toxicity studies demonstrated low acute toxicity in mammals by both the oral, inhalation and dermal routes.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1977

Reliability:

1 (reliable without restriction)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0, 15000 mg/kg

Control animals:

yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Mortality:

no mortality noted

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was > 15000 mg/kg.

Executive summary:

The LD50 was > 15000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

15 000 mg/kg bw

Quality of whole database:

Sufficient to meet data requirements. The study is Klimisch 1.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given:comparable to guidelines/standards.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Ltd., Manston, Kent, UK
- Age at study initiation: 7-8 weeks
- Housing: tubular glass chamber, 2 of each sex
- Diet (e.g. ad libitum): ad libitum, except during 4 hr exposure period
- Water (e.g. ad libitum): ad libitum, except during 4 hr exposure period

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: tubular glass chamber
- System of generating particulates/aerosols: dynamically

TEST ATMOSPHERE
- Brief description of analytical method used: continuously by a high temperature total hydrocarbon analyser

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

13.1 mg/l (near saturation)

No. of animals per sex per dose:

2

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 13.1 mg/L air

Exp. duration:

4 h

Remarks on result:

other: near saturation level

Mortality:

None

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The LC50 for inhalation toxicity in rats is > 13.1 mg/l, which is near the maximum attainable vapor concentration. The LC50 for the test substance is greater than the saturation concentration.

Executive summary:

This study examined the inhalation toxicity of Dilutine M5 to rats. Two male and two female rats were exposed to test atmosphere containing near saturation concentration of the test substance vapors (13.1 mg/l air) for 4 hrs. After exposure, the rats were observed for the next 14 days for mortality. No rats died during the course of the study. Therefore, the LC50 for the test substance is > 13.1 mg/l air. Since this concentration is near the saturation concentration, the LC50 is greater than the saturation concentration. The test substance is not toxic via inhalation, and is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

13 100 mg/m³

Quality of whole database:

Sufficient to meet data requirements. The study is Klimisch 2

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given:comparable to guidelines/standards.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: Noakes, DN, and Sanderson, DM (1969). A method for determining the dermal toxicity of pesticides. Br. J. Industr. Med., 26, 59-64.

GLP compliance:

no

Limit test:

yes

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd, Manston, Kent

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1, 2, or 4 ml/kg

Duration of exposure:

24 hrs

Doses:

1, 2, 4 ml/kg

No. of animals per sex per dose:

2 animals of each sex per dose

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 mL/kg bw

Mortality:

No animals died during the study.

Mortality

Dose ml/kg	Males	Female	Total
1	0/2	0/2	0/4
2	0/2	0/2	0/4
4	0/2	0/2	0/4

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The dermal LD50 for rats is > 4 ml/kg (~3400 mg/ kg bw).

Executive summary:

This study examined the acute toxicity of Dilutine M5 to rats via dermal exposure. 2 female and 2 male rats were exposed to 1, 2, or 4 ml/kg of undiluted test material dermally for 24 hrs. No rats died during the experiment. The dermal LD50 for rats is > 4 ml/kg (~3400mg/kg bw).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

3 400 mg/kg bw

Quality of whole database:

Sufficient to meet data requirements. The study is Klimisch 2.

Additional information

The acute toxicity assessment of Alchisor TAL 111 is based on read-across data from C9-C14 aliphatics (2-25% aromatics) and Alchisor TAL 123.

An acute oral study on C9-C14 aliphatics (2 -25% aromatics) gave an LD50 >15000 mg/kg.

An acute inhalation study on C9-C14 aliphatics (2 -25% aromatics) gave an LC50 >13100 mg/m3.

An acute dermal study on C9-C14 aliphatics (2 -25% aromatics) gave an LD50 >3400 mg/kg.

 

 

 

 

 

 

Justification for selection of acute toxicity – oral endpoint
Two acute oral studies are available. The selected study has the higher Klimisch score.

Justification for selection of acute toxicity – inhalation endpoint
Three acute inhalation studies are available. The selected study used a maximum dose concentration which is greater than the saturated dose concentration.

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

Based on the available read-across data, the substance does not meet the criteria for classification.

However the substance is classified as a Category 1 aspiration hazard based on its physical and chemical properties.