Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%)

Endpoint summary

Description of key information

Acute Toxicity-Oral LD₅₀> 15000 mg/Kg in rats (OECD TG 401)

Acute Toxicity-Dermal LD₅₀> 4mL/Kg (~3400 mg/Kg) in rabbits (OECD TG 402)

Acute Toxicity-Inhalation LC₅₀> 13.1 mg/L (13100 mg/m³) (OECD TG 403)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1977

Reliability:

1 (reliable without restriction)

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.

Reason / purpose for cross-reference:

read-across: supporting information

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

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 15 000 mg/kg bw

Mortality:

no mortality noted

Interpretation of results:

other: Not classified

Remarks:

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:

One key read across study from structural analogues available for assessment.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

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

Key result

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

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 air

Quality of whole database:

One key substance specific and one supporting read across study from structural analogues available for assessment.

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:

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

Key result

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

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:

no adverse effect observed

Dose descriptor:

LD50

Value:

3 400 mg/kg bw

Quality of whole database:

One key study available for assessment.

Additional information

Acute inhalation and dermal toxicity data is available for Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). However, there is no acute oral toxicity data available for Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, aromatics (2-25%). Data is available for structural analogues, Hydrocarbons, C9-C10, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) and C9-C14 aliphatic solvents, 2-25% aromatic. This data is read across to Hydrocarbons, C9 -C12, n-alkanes, isoalkanes, cyclics, aromatics (2 -25%) based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Acute Oral Toxicity

In a key acute oral toxicity (ExxonMobil, 1977a), male and female rats were exposed via oral gavage to the hydrocarbons, C9-C10, n-alkanes, isoalkanes, cyclics, 2-25% aromatics at doses of 0 or 15000 mg/Kg. Based on the lack of effects of mortality observed, the LD₅₀ was determined to be >15000 mg/Kg bw.

Acute Inhalation Toxicity

A key acute toxicity study (Shell, 1977a) examined the inhalation toxicity of hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics in 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 was determined to be > 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.

A supporting study (Sasol, 1990) examined the toxicity of a C9-C14 aliphatic solvent (2-25% aromatics) in rats via aerosol inhalation. Five male and five female rats were exposed to aerosol of the test substance for 4 hrs. The test concentration was 1.58 mg/L, the maximum concentration with 25% of particles under 1 micron. Animals were observed for clinical signs and mortality at 0.5, 1.0, 2.5, 4.5, and 6.0 hrs after start of exposure, and daily thereafter for the next 14 days. Body weights were taken on days 0, 7, and 14. All animals were sacrificed on day 14, and gross necropsies performed. Animals exhibited symptoms of piloerection, activity decrease, ptosis, and polyuria beginning at the 1 hr observation, and persisting in some cases to the 6 hr observation. By the day 1 observation, all symptoms had resolved. No mortality was observed during the experiment. The 4-hr LC₅₀ for rats via inhalation of aerosol was determined to be >1.58 mg/L. The test substance is not classified an inhalation toxin under OECD GHS or EU CLP guidelines.

Acute Dermal Toxicity

A key study (Shell, 1977a) examined the acute toxicity of hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics in 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 was determined to be > 4 mL/Kg (~3400 mg/Kg bw).

Justification for classification or non-classification

Based on available substance and read across data, Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics is minimally toxic via ingestion where the LD₅₀ is >15000 mg/Kg, via dermal exposure where the LD₅₀ is >3400 mg/Kg, and by inhalation where the LC₅₀ is >13100 mg/m³. These findings do not warrant classification under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP).

Hydrocarbons, C9-C12, n-alkanes, isoalkanes, cyclics, 2-25% aromatics is classified under EU CLP guidelines as a Category 1 aspiration hazard based on its physical and chemical properties (hydrocarbon fluid, viscosity ≤ 20.5 mm²/s).