Registration Dossier

Administrative data

Description of key information

Acute oral toxicity: LD50 >3,000mg/kg in rat for both males and females
Acute inhalation waived
Acute dermal toxicity: LD50>2000mg/kg in rat

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
3 000 mg/kg bw

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
2 000 mg/kg bw

Additional information

Acute oral toxicity:

The oral acute toxicity of the Source Substance, cyclohexyl salicylate, to young adult male and female Sprague-Dawley rats was studied under GLP in accordance with EU Method B.1. The LD50 value of cyclohexyl salicylate was greater than 2000 mg/kg in an acute oral toxicity study with male and female Sprague-Dawley rats.

Limited data to support lack of acute toxicity via the oral route is available on Benzyl salicylate (Target Substance) and the available results support the read across proposal that the substance is not classified with regards to acute oral toxicity in accordance with regulation (EC) No 1272/2008.

Acute inhalation toxicity:

Testing by the inhalation route in accordance with column 2 of Annex VIII of 1907/2006/EC, is considered to be inappropriate as exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance (0.0104 Pa at 25°C) and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.

Acute dermal toxicity:

The acute toxicity of the Source Substance, Cyclohexyl salicylate was studied under GLP in accordance with the EU Method B.3. Five female and five male young adult rabbits of the strain "Kleinrusse" were used in the test.

The LD50 value in an acute dermal toxicity study with rabbits was LD50 > 2000 mg/kg bw and the substance is not classified for acute dermal toxicity according to the CLP regulation.

Limited data to support lack of acute toxicity via the dermal route is available on Benzyl salicylate (Target substance) and the available results support the read across proposal that the substance is not classified with regards to acute dermal toxicity in accordance with regulation (EC) No 1272/2008.

To address toxicological endpoints as part of the REACH registration of Benzyl Salicylate (Target Substance) it is proposed to read-across to Cyclohexyl Salicylate (Source Substance).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

TheTarget Substance and Source Substance have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.

For classification and labelling purposes this indicates that the structural analogue is relatively harmless and would not, in itself, be classified in accordance with Regulation (EC) No 1272/2008 (CLP). The registration substance is considered to have similar properties and is therefore not classified in accordance with CLP.


Justification for selection of acute toxicity – oral endpoint
The oral acute toxicity of (the Source Substance), cyclohexyl salicylate, to young adult male and female Sprague-Dawley rats was studied under GLP in accordance with EU Method B.1. The LD50 value of cyclohexyl salicylate was greater than 2000 mg/kg in an acute oral toxicity study with male and female Sprague-Dawley rats.
Klimisch4-rated data to support lack of acute toxicity via the oral route is available on the Target Substance and the available results support the read across proposal that the substance is not classified with regards to acute oral toxicity in accordance with regulation (EC) No 1272/2008.

Justification for selection of acute toxicity – dermal endpoint
The LD50 value of the Source Substance, cyclohexyl salicylate, in an acute dermal toxicity study with rabbits was LD50 > 2000 mg/kg bw and the substance is not classified for acute dermal toxicity according to the CLP regulation.
Limited data to support lack of acute toxicity via the dermal route is available on the Target substance and the available results support the read across proposal that the substance is not classified with regards to acute dermal toxicity in accordance with regulation (EC) No 1272/2008.

Justification for classification or non-classification

No deaths occurred in all animals administered a dose of 2000mg/kg of the structural analogue, Cyclohexyl Salicylate via the oral and dermal route of exposure.

To address toxicological endpoints as part of the REACH registration of Benzyl Salicylate (Target Substance) it is proposed to read-across to Cyclohexyl Salicylate (Source Substance).

The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.

The Target Substance and Source Substance have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.

For classification and labelling purposes this indicates that the structural analogue is relatively harmless and would not, in itself, be classified in accordance with Regulation (EC) No 1272/2008 (CLP). The registration substance is considered to have similar properties and is therefore not classified in accordance with CLP.