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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-07-01 to 2004-07-22
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
GLP compliance:
Test type:
acute toxic class method
Limit test:

Test material

Constituent 1
Reference substance name:
CD 605 XX
CD 605 XX
Test material form:
solid: crystalline
Details on test material:
- Physical state: brown crystalline powder

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River Deutschland GmbH, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 7-8 weeks
- Weight at study initiation: males 181-205 g, females 130-140 g
- Fasting period before study: in the afternoon of day -1 (at approx. 16:00 h) over night
- Housing: in groups up to three animals of one gender per cage
- Diet (e.g. ad libitum): ad libitum (Kliba No. 3438.0.25, Provimi Kliba SA, CH-4303 Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): ad libitum (municipal tap water; Stadtwerke Biberach)
- Acclimation period: 5 to 7 days

- Temperature (°C): 22 +-2
- Humidity (%): 45 - 75
- Air changes (per hr): min. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
other: 0.5 % aqueous hydroxyethylcellulose
Details on oral exposure:
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of prior experience, 200 mg/kg bw was chosen as the initial dose. The second dose was selected based on the animals´ response to 200 mg/kg.
200, 2000 mg/kg bw
No. of animals per sex per dose:
200 mg/kg bw: 3 female
2000 mg/kg bw: 3 female
200 mg/kg bw: 3 male
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made once to twice daily. Body weight was recorded on Day -1 and during the observation period, the body weight of all animals was recorded on Day 1, 2, 8 and 15, respectively.
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight
None performed.

Results and discussion

Effect levels
Dose descriptor:
other: ALD
Effect level:
> 200 - < 2 000 mg/kg bw
Based on:
test mat.
200 mg/kg: No mortality occurred in either male or female rats.
2000 mg/kg: Two out of three females died. Two rats were found dead in the morning of Day 2. Due to the marked mortality in females, no male rats were treated.
Clinical signs:
other: 200 mg/kg, male: Clinical signs were observed on Day 1 only in all three rats treated and included piloerection (2.5 h to 5.25 h post administration) and sedation (4.0 h to 5.25 h post administration). Rats returned to normal on Day 1 (6.25 h post adminis
Gross pathology:
200 mg/kg: Except slight changes in the uterus of one female animal (horns filled with aqueous liquid), no gross macroscopic alterations were observed at necropsy.
2000 mg/kg: At necropsy of two female animals, which died on Day 1, gross macroscopic changes were observed in the lungs (discoloration), the stomach (discoloration of the mucosa, multiple bleedings in the wall) and the intestines (empty lumen). One animal, in addition, showed alterations in the skin around the nose (red discharge) and in the liver (stasis).
No changes were seen at necropsy of the female animal, which survived the entire study period.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
according to CLP
An approximate lethal dose (ALD) for the test item between 200 and 2000 mg/kg in rats was determined.
Based on the dose effect relationship the LD 50 was estimated to be 1000 mg/kg bw according to Annex 3b of the replaced OECD 423, adopted in March 1996. Therefore, the substance has to be classified as harmful if swallowed.