Registration Dossier

Administrative data

Description of key information

Oral: LD50= > 5000 mg/kg bw, male rat, equiv. to OECD 401, M B Research Laboratories Inc. 1979
Dermal: LD50= > 2000 mg/kg bw, male/female rabbit, equiv. to OECD 402, M B Research Laboratories Inc. 1979

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
5 000 mg/kg bw
Quality of whole database:
The available information as a whole meets the tonnage driven information requirements of REACH. The substance shows no evidence of acute toxicity by the oral or dermal routes.

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:
The available information as a whole meets the tonnage driven information requirements of REACH.

Additional information

Acute Oral:

The pre-GLP study was performed following a method similar to OECD 401 to assess the acute oral toxicity potential of the test substance to male Wistar rats. The test material was administered as a single oral dose to a group of 10 male rats orally, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. Animals were not examined for gross pathology. One animal died on Day 1 at this dose level. Lethargy, ataxia and ptosis were noted in five or more animals 3-4 hours post dose. Isolated instances of prostration and negative righting reflex were noted 3-4 hours post dose. Lethargy, ptosis, piloerection and chromorhinorrhea were noted in five or more animals on Days 1 and 2 and periodically through to Day 5. All surviving animals were normal on Day 6. Isolated instances of lethargy, ptosis, and chromorhinorrhea were sporadically noted on Days 7 through to 14. Under the conditions of this study the LD50 was determined to be >5000 mg/kg.

 

Acute Dermal:

The pre-GLP study was performed following a method similar to OECD 402 to assess the dermal toxicity of the test material to New Zealand White rabbit. The test substance was evaluated in 10 New Zealand white rabbits. A dose of 2000 mg/kg test substance (undiluted), was applied to intact and abraded clipped skin site under a occlusive dressing for 24 hours. Skin observations were made 24 hours after patch removal and then daily for 14 days for signs of toxicity, pharmacological effects and mortality. One test animal died on day ten; pre-death toxic signs included anorexia, diarrhoea, mucus in stool, lethargy, and ptosis. Isolated instances of diarrhoea were periodically noted in 3 animals. Six animals remained normal throughout the observation period. Very slight to well defined erythema and very slight to slight edema were noted at 24 hours. Under the conditions of this study the LD50 is considered to be greater than 2000 mg/kg.


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

Justification for selection of acute toxicity – dermal endpoint
Only one study available.

Justification for classification or non-classification

The substance does not meet classification criteria under EU Directive 67/548/EEC for acute toxicity.

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for acute toxicity.