Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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).