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Administrative data

Description of key information

The NOAEL for oral is 3.5 mg/kg/day.
The NOAEL for inhalation is 0.21 mg/m3.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
3.5 mg/kg bw/day
Study duration:
subacute
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
0.21 mg/m³
Study duration:
subacute
Species:
rat

Additional information

Oral:

In a subchronic toxicity study the substance was administered to SPF SD rats four weeks/male and female/dose in suspended 5 (w/v) % arabic gum water solution, by gavag eat dose levels of 0, 3.5, 11.0 & 35.0 mg/kg bw/day.

The substance induced toxic changes due to irritation.

The NOAEL is 3.5 mg/kg/day based on irritative property in Rats by the 30 days oral administration.

In a screening study by OECD 422, this study's result shows irritative property of this substance causes local effects but absence of systemic effects. On the view point of the endpoint on repeat toxicity consideration, male' adverse effect during 51 days exposure is effective but female's adverse effect during this exposure period is not reliable due to maternal toxicity in this combined repeat dose and reproductive/developmental toxicity screening study.

The NOEL and LOAEL for oral repeat dose in male is 2.5 mg/kg/day by using OECD 422 test method.

Inhalation:

In a subacute inhalation toxicity study, this substance was administered to 5 of CD rats (Spraque-Dawley) /sex/concentration by dynamic whole body exposure at concentrations of 0, 0.21, 0.87 & 2.27 mg/m3 for 6 hours per day,  5 days/week for 4 consecutive weeks.

The NOAEL is 0.21 mg/m3 based on 28 -day inhalation study in rats.

 

The commercial product (>355 um) has practically no micronized particle size (<10 um).

However, one should consider the DNEL for inhalation for workers because of any accidental release of this product at polymer manufacturers plant site.

Regarding dermal consideration, low predicted levels of dermal exposure to humans as shown in the chemical safety assessment, physicochemical properties indicating low potential for dermal penetration (log Pow 1.16) and absence of systemic toxicity in skin irritation, eye irritation and sensitisation studies.

This subchronic toxicity endpoint is waived based on REACH annex IX Section 8.6.2 column 2 on grounds that two reliable repeat dose studies are available by the oral route one of which is shows an extended ca 50 days of exposure for male. These clearly identify that the only significant effects seen are related to the irritant nature of this substance, therefore there are no other findings of toxicological significance.

Justification for classification or non-classification

Repeat toxicity-irreversible damage after repeat exposure: non-classification