2-tert-butylcyclohexyl ethyl carbonate

Endpoint summary

Description of key information

Acute toxicity: oral: LD50 > 2000 mg/kg bw (sim. to OECD 401, K, rel. 1)

Acute toxicity: dermal: LD50 > 5000 mg/kg bw (sim. to OECD 402, RA, rel. 4)

Acute toxicity: inhlalation: waiver

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:

The Key study is performed similarly to the OECD guideline 401 with minor deviations: material tested as a suspension in CMC; it could have been tested undiluted. Certificate of analysis of the test substance is not included, some details on test material and tested animals are missing. (Klimisch score = 2)

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:

5 000 mg/kg bw

Quality of whole database:

The RA study (Klimisch score = 4) was conducted similarly to OECD Guideline 402 with deviations: purity of test item and on animals, protocol and results not detailed. A group of New Zealand White rabbits (3/sex/dose) were given a single dermal application of o-tert-butylcyclohexyl acetate at 5000 mg/kg bw.

Additional information

Acute toxicity: oral

In an acute oral toxicity study performed similarly to OECD guideline 401 (Potokar, 1981), 10 adult male CF-1 mice were administered a single oral dose of test compound suspended in CMC at 2000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and some of them were necropsied for macroscopic observations.

No mortality and no clinical signs were observed including narcotic effect. Bodyweight increased normally. In these test conditions, oral LD50 in males was considered higher than 2000 mg/kg bw.

Acute toxicity: inhalation

No relevant study was available for this endpoint. However, an acute study by inhalation is available (2h at 1%), showing effects that the substance is not of toxicological concern by inhalation. Moreover, considering that the substance is not skin and eye irritating and it does not induce mortality or systemic effects by oral route, no respiratory irritation is anticipated that could increase inhalation absorption.

However, in accordance with column 2 of REACH Annex VIII (§8.5), the acute toxicity by inhalation does not need to be conducted since the acute toxicity is already provided for the oral and the dermal routes.

Acute toxicity: dermal

For acute dermal toxicity, a weight of evidence strategy was followed to cover this endpoint.

In an acute dermal toxicity study (limit test) performed similarly to OECD Guideline 402 (RIFM, 1976) with the analogue, a group of ten rabbits (strain, sex and age unspecified) were given a single dermal application of o-tert-butylcyclohexyl acetate at 5000 mg/kg bw. Animals were then observed for mortality and clinical signs for 14 days.

No mortality was observed during the study. Slight to moderate erythema and edema were observed in all rabbits after application without any other detail. One rabbit showed diarrhea. The dermal LD50 of test item was considered to be higher than 5000 mg/kg bw in rabbits.

Also, no adverse effects were observed in the OECD guideline 404 study performed on 1994 on the target substance.

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008.

Self-classification:

Based on the available data no additional self-classification according to Regulation (EC) No. 1272/2008 and the CLP is proposed regarding:

- dermal toxicity and,

- specific target organ toxicity -single exposure and

- aspiration hazard (based on the acute oral toxicity study)

Based on the available data, the substance is not classified for the acute oral toxicity according to Regulation (EC) No. 1272/2008 but it is self-classified in category 5 according to the GHS.

No reliable data available for acute inhalation toxicity.