Registration Dossier

Administrative data

Description of key information

Oral: Two studies are available with a LD50 of 2250 mg/kg bw in mice and 2565 mg/kg bw in rats
Dermal: Multiple studies are available with a LD50 of the key study of >2000 mg/kg bw.
Inhalation: A study is available with a LC50 of the key study of 12200 mg/m3 air.
Other routes: A study is available with the LD50 of 1460 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 250 mg/kg bw
Quality of whole database:
2 (reliable with restrictions)

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
12 200 mg/m³
Quality of whole database:
2 (reliable with restrictions)

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:
2 (reliable with restrictions)

Additional information

Oral:

2 studies are referenced in the dossier that were qualified as Klimisch 2, because the method used was similar to OECD 401, but were not performed under GLP. These are as follows:

1) Mus musculus: LD50 = 2250 mg/kg bw (Bier, 1979)

2) Rat: LD50 (M/F) = 2565 mg/kg bw, LD50 (M) = 2742 mg/kg bw, LD50 (F) = 2360 mg/kg bw (Goldenthal, 1974)

For the other studies no actual report or article was available. The results are as follows:

3) Mouse: 1940 <= LD50 <= 2263 mg/kg bw (Abe, 1984)

4) Mouse: 1940 <= LD50 <= 2263 mg/kg bw (McCormick, 1974)

5) Rat: 2000 <= LD50 <= 2500 mg/kg bw (Ignatev, 1965)

6) Mouse: LD50 = 1996 mg/kg bw (Sado, 1973)

7) Mouse (non SPF): LD50 = 1250 mg/kg bw (Schafer, 1985)

8) Cat, dog, rabbit: LD50 = 2000 mg/kg bw (Ellinger, 1923)

9) Rat: LD50 = 2530 mg/kg bw (Marhold, 1977)

10) Mouse: LD50 = 2370 mg/kg bw (Mc Cormick, 1973)

Based on the outcome of the key studies the LD50 is >2000 mg/kg bw

Dermal:

3 studies are referenced in the dossier. Only one was available for review and showed an LD50 in rabbit of > 2000 mg/kg bw (Goldenthal, 1974). The two other studies also in rabbits seem to confirm this finding ( LD50 >= 2000 mg/kg bw (Opdyke, 1973),

LD50 >= 5000 mg/kg bw (Bio-Fax, 1973))

Inhalation:

In an acute inhalation study rats were exposed to 12200 mg/m3 test substance dust in air (Goldenthal, 1974). No mortality was reported, therefore the LC50 was > 12200 mg/m3.

Other routes:

A study is reference in the dossier. The result is as follows:

Mouse: LD50 = 1460 mg/kg bw (Caujolle, 1958)


Justification for selection of acute toxicity – oral endpoint
This study was conducted according to a method which equivalent or similar to OECD guideline 401 using mice.

Justification for selection of acute toxicity – inhalation endpoint
This study was conducted according to a reliable method using rats.

Justification for selection of acute toxicity – dermal endpoint
This study was conducted according to a reliable method using rabbits.

Justification for classification or non-classification

Oral LD50 = >2,000 mg/kg

Dermal LD50 = >2,000 mg/kg

Inhalation LD50 = >5,000 mg/m3

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.1.1 the substance is not classified for the acute toxicity endpoint.

Specific Target Organ Toxicity - Single ExposureNo specific target organ toxicity was observed following single exposure to the substance via any route at doses triggering classification for STOT SE 1 or 2.STOT SE 3 is not triggered as no signs of respiratory tract irritation were observed after first exposure (nasal irritation signs were observed in a repeated dose study (Bensen, 1981) but only from Day 4).Therefore, classification with STOT SE is not assigned.