Registration Dossier

Administrative data

Description of key information

Following single oral treatment of rats LD50 is 242 mg/kg bw. Follwing dermal application to rabbits the LD50 was 2050 mg/kg bw. Clinical signs included hypoactivity, salivation, tremors and convulsions. The skin of dermal treated rabbits show  additionally severe erythema and burns. 
The databases on acute inhalation toxicity of m-cresol in animals is very limited and does not allow final conclusion.
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Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
242 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
Value:
2 050 mg/kg bw

Additional information

There is no study according to the current OECD test guideline, but the given information is sufficient to evaluate this endpoint.

ORAL APPLICATION

Single oral application of undiluted test substance by< gavage to 5 rats/dose group and an observation time up to 14 days resulted in an LD50 value of 242 mg/kg bw, Clinical signs included hypoactivity, salivation, tremors and convulsions (Ind Bio-test Lab Inc 1969).

DERMAL APPLICATION

Following dermal application to rabbits of undiluted test substance and an observation time for 14 days the

LD50 was 2050 mg/kg bw (Industr. Bio-test Lab Inc 1969).. Clinical signs included hypoactivity, salivation, tremors and convulsions; the treated skin showed severe erythema and burns.

INHALATION EXPOSURE

No rat died during the 1 hour exposure against 710 mg/m³ (not further specified, Industr. Bio-tes Lab 1969). In an 8-hour inhalation study with saturated vapor, no ratl died and no signs of intoxication were observed (Mellon Inst Ind Res 1949). In Pereima 1975 cited in WHO 1995 the LC50 in rats was reported to be 58 mg/m³ but exposure period and other relevant data were not available.Clinical signs of intoxication included irritation of mucous membranes, neuromuscular excitation and convulsions.

Overall, the databases on acute inhalation toxicity of m-cresol is very limited and does not allow final conclusion. Nevertheless, further testing is not required because m-cresol is evaluated as corrosive and is classified /labelled accordingly. This is in accordance with the specific rules (Column 2) of Annex VIII No.8.5 of Regulation (EC) No. 1907/2006 (REACH), a study does not generally need to be conducted if the substance is classified as corrosive to the skin.

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Justification for classification or non-classification

Under R67/548/EEC /19. ATP m-and p-cresol as well as o-cresol are classified as toxic in contact with skin and if swallowed. R24/25.

Based on the cited acute data with oral and dermal exposure a change in classification and labelling could be considered, but the data base is very limited. Therefore the present classification is accepted. Referring to acute inhalation exposure the given information is insufficient to evalutate the need for classification because important experimental details are not given . Therefore a classification is not required.

According to Regulation (EC) No. 1272/2008 the substance is allocated to category 3 for acute toxicity by oral and dermal route; Hazard Communication H301 and H311