Hydrocarbons, terpene processing by-products

Endpoint summary

Description of key information

In an acute oral toxicity study performed according to OECD guideline 401 and GLP compliant, LD50 > 2000 mg/kg bw
In acute dermal toxicity limit tests performed according to OECD guideline 402 and GLP compliant, LD50 > 2000 mg/kg bw 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to other study

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

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

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

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

None

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

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

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

GLP studies conducted in compliance with OECD Guideline 402 without any deviation.

Additional information

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.

In acute dermal toxicity studies (limit tests) performed according to OECD Guideline 402 and in compliance with GLP with two different batches (low and high content of alcohols), Sprague Dawley rats (5/sex/dose) were given a single dermal application of Hydrocarbons, terpene processing by-products at 2000 mg/kg bw. The test item was placed onto the intact skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semi-occlusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. In both studies, no mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. Cutaneous reactions (erythema) were noted from 24 or 48 h post-dose in all females and were totally reversible on Day 5 in females. Dryness was noted on Day 5 in all females and was totally reversible on Day 8. Body weight evolution of the animals remained normal throughout the study. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The combined dermal LD50 of test item was considered to be higher than 2000 mg/kg bw in rats.

Justification for selection of acute toxicity – oral endpoint
Only one study available for this endpoint

Justification for selection of acute toxicity – inhalation endpoint
No study was available and in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since acute toxicity is already assessed by two different routes of exposure (oral and dermal routes). Also, acute toxicity studies by oral and dermal routes showed very low toxicity, with high LD50 values.

Justification for selection of acute toxicity – dermal endpoint
No study could be selected because two recent equally valid studies were available for this endpoint.

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in rats therefore the substance does not need to be classified for acute toxicity according to the Directive 67/548/EEC and the CLP Regulation (EC) No. 1272 /2008. However, based on its viscosity, the substance should be classified for aspiration hazard: - H304, May be fatal if swallowed and enters airways according to the CLP regulation (EC) No. 1272 /2008 - Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.