Hydrocarbons, terpene processing by-products

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 November - 13 December 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline 401 without any deviation.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrocarbons, terpene processing by-products

EC Number:

273-309-3

EC Name:

Hydrocarbons, terpene processing by-products

Cas Number:

68956-56-9

Molecular formula:

Not applicable for UVCB substance

IUPAC Name:

Hydrocarbons, terpene processing by-products

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): DERTOL 20 DD (Hydrocarbons, terpene processing by-products)
- Physical state: Colourless Liquid
- Date of receipt: 12 November 1990
- Storage condition of test material: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: IFFA CREDO, L' ARBRESLE, France
- Age at study initiation: 2 months
- Weight at study initiation: Males: 192.1 ± 6.7 g, females: 182.2 ± 4.3 g
- Fasting period during the study: Animals were placed on a hydric diet on the day before the trial, i.e. 16 h before treatment. Food was given to the animals 4 h after the administration of the test item.
- Housing: Animals were housed in groups of 5/sex in makrolon boxes (46.5 x 31 x 19 cm)
- Diet: Food (UAR A04C), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 61 ± 3 %
- Air changes: 14 cycles/h
- Photoperiod: 12 h dark / 12 h light

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Maximum dose volume administered: 2.3 mL/kg bw
- Test material was administered undiluted.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed 3 h after dosing and subsequently once daily for 14 days. Mortality was observed at least twice daily.
Bodyweight was recorded on Day -3, 0 (just before treatment), 4, 7 and 14.
- Necropsy of survivors performed: Yes; on Day 14 all animals were sacrificed for gross necropsy examination.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

- No mortality was observed.

Clinical signs:

other: - A decrease in motor coordination was observed in all animals immediately after product administration. 4 h later, motor coordination turned back to normal. - No signs evidencing any toxicity at the level of the central nervous system or neuro-vegetative

Gross pathology:

- No abnormalities were noted at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 for DERTOL 20 DD (Hydrocarbons, terpene processing by-products) is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline 401 and in compliance with GLP, groups (5/sex/dose) of Sprague Dawley rats were given a single oral dose of DERTOL 20 DD (Hydrocarbons, terpene processing by-products) at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination.

No mortality was observed. A decrease in motor coordination was observed in all animals immediately after product administration. 4 h later, motor coordination turned back to normal. No signs evidencing any toxicity at the level of the central nervous system or neuro-vegetative system were noted. The weight growth of the male and females appeared normal for animals from this strain. No abnormalities were noted at necropsy at the end of the study. In this study, the combined oral LD50 of DERTOL 20 DD (Hydrocarbons, terpene processing by-products) was considered to be higher than 2000 mg/kg bw in rats.

The oral LD50 for DERTOL 20 DD (Hydrocarbons, terpene processing by-products) is higher than 2000 mg/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).