Hydrocarbons, C9-C12, n-alkanes, isoalkanes, <2% aromatics

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Study period:

1988/5/10 - 1988/5/24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to OECD test guideline 401. GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, C9-C11, cyclics, < 2% aromatics

IUPAC Name:

Hydrocarbons, C9-C11, cyclics, < 2% aromatics

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
- Age at study initiation: 9 weeks
- Weight at study initiation: males: 179-197g, females: 162-180g
- Fasting period before study: 12-18h
- Housing: individually
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, batch 95/88 rat maintenance diet, ad libitum
- Water (e.g. ad libitum): community tap water from Itingen, ad libitum
- Acclimation period: at least one week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: undiluted, as delivered by sponsor
- Amount of vehicle (if gavage): 5000 mg/kg
- Justification: the oral administration was used, because this is one possible route of human exposure during manufacture, handling and use of the test article

Doses:

5000 mg per kg bodyweight

No. of animals per sex per dose:

5 males and 5 females (one dose)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations were made as to the nature, onset, severity, and duration of toxicological signs 4 times during day one, and once per day during day 2-15. Body weights were recorded on the test day prior to dosing and on Day 8 and Day 15, and at death for those which succumbed.
- Necropsy of survivors performed: yes

Statistics:

The LOGIT-model could not be applied to the observed rates of death. The toxicity was estimated without use of a statistical model.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality

Clinical signs:

5000 mg/kg: sedation, dyspnea, hunched posture, ruffled fur
All animals had recovered until day 5 of the observation

Body weight:

All animals displayed increases in body weight over their Day 0 values

Gross pathology:

All animals were free of abnormalities at postmortem examination.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for the test material is >5000 mg/kg. Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Executive summary:

C9 -C11 cyclic aliphatics were administered via oral gavage to 5 male and 5 female rats at a dose of 5000 mg/kg to assess acute oral toxicity.  Animals were observed daily for 15 days post dosing.  At a dose of 5000 mg/kg, signs of toxicity were sedation, dyspnea, hunched posture and ruffled fur. All animals had recovered until day 5 of observation and survived to study termination. All animals were free of abnormalities at postmortem examination.  All surviving animals displayed increases in body weight over their day 0 values.  The acute oral LD50 for C9 -C11 cyclic aliphatics is >5000 mg/kg.  Classification as an oral toxicant is not warranted under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.