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Description of key information

In an acute oral toxicity study performed according to OECD guideline 423 and GLP compliant, LD50 > 2000 mg/kg bw
In an acute dermal toxicity limit test 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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Study performed according to OECD guideline 423 and GLP compliant.

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:
Study performed according to OECD guideline 402 and GLP compliant.

Additional information

In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, 6 Sprague Dawley female rats were given a single oral (gavage) dose of Terpinolene multiconstituent 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. Decrease in spontaneous activity, piloerection and mydriasis were noted during the first hours of the test, however animals recovered a normal behaviour between 24 and 48 h post dose. Lower body weight gain was noted in treated animals on Day 2 compared to the historical control group. No macroscopic abnormalities were observed at necropsy. In this study, the oral LD50 of Terpinolene multiconstituent was considired to be higher than 2000 mg/kg bw in female rats.

In an acute dermal toxicity study (limit test) performed according to OECD Guideline 402 and in compliance with GLP, Sprague Dawley rats (5/sex/dose) were given a single dermal application of Terpinolene multiconstituent at 2000 mg/kg bw. The test item was placed directly on dorsal area of the skin representing approximately 10 % of the total body surface of the animals. The test site was then covered by a semiocclusive dressing for 24 h. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. No mortality and no clinical signs were observed during the study. Cutaneous reactions (erythema, dryness and scab) were noted on the treated area of three females and three males, 24 or 48 h after the test item application and were totally reversible on Day 9 in all animals. Body weight gain of the treated animals was not affected by the test item. No macroscopic abnormalities were observed at necropsy. The combined dermal LD50 of Terpinolene multiconstituent 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
Only one study available for this endpoint

Justification for classification or non-classification

Oral and dermal LD50 are higher than 2000 mg/kg bw in rats therefore Terpinolene multiconstituent does not need to be classified for acute toxicity according to the Annex VI to the Directive 67/548/CEE and the CLP Regulation (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 regulation (EC) No. 1272/2008

- Xn, R65, Harmful: may cause lung damage if swallowed according to the Directive 67/548/EEC.

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