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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute toxicity via oral route:
oral  LD50 rat > 2000 mg/kg bw (OECD 401, GLP; MHLW, 2002), LD50 rat > 10000 mg/kg bw (standardized test protocol; BASF 1978).

Acute toxicity via dermal route:
Not relevant

Acute toxicity via inhalation route: 

No mortality or systemic toxicity was observed in a 7-h inhalation hazard test (IHT, BASF, 1978) and in a 5-d bioavailability study (BASF, 33I0110/91008, 1994; see section 7.5.2).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
not specified
GLP compliance:
Limit test:
Specific details on test material used for the study:
- Batch No.: 4879
other: Crj; CD(SD) IGS
Details on test animals or test system and environmental conditions:
- Source: SD rats (SPF, Crj: CD (SD) IGS) produced by Atsugi Breeding Center, Charles River Laboratories Japan, Inc.
- Age at study initiation: Five-weeks-old male and female rats.
- Weight at study initiation: males weighed 138 to 152 g (mean: 145.0 g); females weighed 125 to 136 g (mean: 129.4 g).
- Fasting period before study: Yes, 17 to 18 hours before administration.
- Housing: Male and female rats were housed separately in bracket cages with metal wire-mesh flooring (300 w x 410 d x 200 h mm). Each cage housed one or three rats during quarantine and acclimation, and one rat after grouping.
- Diet: The rats took freely CRF-1, or gamma-irradiated solid feed produced by Oriental Yeast Co., Ltd., using metal diet feeders except for 17 to 18 hours before and about four hours after administration.
- Water: The rats drank tap water of Sapporo freely from automatic water feeders.
- Acclimation period: All animals were subjected to eight days of quarantine and acclimation. General condition was checked once a day, and body weight was checked twice a day. During the period of quarantine and acclimation, no abnormality was found in the animals.

- Temperature (°C): 23 ± 3 (measured 22 to 24)
- Humidity (%): 55 ± 10 (measured 51 to 58)
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12 (with artificial lights from 8 a.m. to 8 p.m.)
Route of administration:
oral: gavage
other: Carmellose sodium
Details on oral exposure:
- Concentration in vehicle: 1% carmellose sodium solution
- Lot no.: lot No. 9813

0, 2000 mg/kg bw
No. of animals per sex per dose:
Control animals:
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least once daily
- Necropsy of survivors performed: yes
Bartlett’s test was applied to body weight, body weight increase, and body weight increasing rate to analyze equality of variance. The check items were analyzed by the one-way analysis of variance in case of equal variance and by the Kruskal-Wallis test in case of unequal variance. If the one-way analysis variance indicated a significant difference, the treatment group was compared with the control by the Dunnett’s test. If the Kruskal-Wallis test indicated a significant difference, the treatment group was compared with the control by the Mann-Whitney U test. In comparison with the control, averages and standard deviations of the groups were used, and a critical rate of 5 % or less was regarded statistically significant.
Preliminary study:
In the preliminary test, 2000 mg/kg of the test substance was administered in a single dose to three each of male and female Crj: CD (SD) IGS rats, and no death was observed. In accordance with the result of the preliminary test, only doses of 2000 mg/kg bw, or the limit dose specified by OECD Guidelines for the Testing of Chemicals (401) were used, and 1 % carmellose sodium solution as control.
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
not observed
Clinical signs:
other: not observed
Gross pathology:
In the control group, one male had unilateral yellowish white patches on the kidney and another male had unilateral pyelectasis, while females had no abnormality. In the 2000 mg/kg group, no abnormality was found for both males and females.
Other findings:
On day 1, all rats of the 2000 mg/kg group discharged yellow feces. On day 2 and on, no abnormality was found for both males and females.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP and guideline compliant study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity via oral route:

For the oral exposure pathway two limit tests were available.

One OECD guideline 401 compliant study under GLP (MHLW 2002) reported no mortalities, clinical signs or necropsy findings in male and female CD rats after oral treatment with 2000 mg/kg bw per oral gavage. After an observation period of 14 d, the LD50 is > 2000 mg/kg in rats.

The second test was performed according to a standardized internal method, which is in principle comparable to the OECD guideline 401, but for which GLP compliance was not confirmed (BASF 1978). Since there were no mortalities, clinical signs or necropsy findings observed in male and female Sprague-Dawley rats dosed with 10000 mg/kg bw after a 14 d observation period, the acute oral LD50 is > 10000 mg/kg bw and the LD0 is >= 10000 mg/kg in rats.

Acute toxicity via dermal route:

No data were available for acute dermal toxicity. In accordance with Regulation (EC) 1907/2006 (REACH), the acute dermal route was waived as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 >2000 mg/kg, see section 7.2.1). Additionally, no systemic effects have been observed in the in vivo studies with dermal exposure (see section 7.3.1).

Acute toxicity via inhalation route:

For the acute inhalation two studies were considered in a weight of evidence approach. An acute inhalation hazard test (IHT), performed in principle as described in the OECD Guideline 403, is available (BASF, 1978). In this study, rats were exposed for a period of 7 hours to an atmosphere saturated with vapors of the volatile components of the test substance at 20 °C. No mortality was observed during this test. Additionally, in a GLP-compliant bioavailability study, male Wistar rats were exposed for 5 days to 60 mg/m³ test substance; the observation period was 0, 3, 10, 31 and 60 d (BASF, 33I0110/91008, 1994; see section 7.5.2). No effects on mortality, clinical signs, body weights and body weight gains were found. Clearance half time was ca. 50 d in the lung; no systemic bioavailability was found in other organs. 

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. Based on the available toxicity data and the physical-chemical properties of the test substance, it is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the ninth time in Regulation (EC) No 2016/1179.