Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 944-280-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- The reliability of the original study used in Read Across is 2. Justification for Read Across is given in section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Similar Substance 01 - BB 041
- IUPAC Name:
- Similar Substance 01 - BB 041
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif:RAIf(SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland.
- Females (if applicable) nulliparous and non-pregnant: yes.
- Age at study initiation: 7-8 weeks.
- Weight at study initiation: 157-190 g.
- Fasting period before study: overnight, prior to dosing
- Housing: 5/cage/sex.
- Diet (e.g. ad libitum): NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland) ad libitum.
- Water (e.g. ad libitum): tap water ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C.
- Humidity: 55 ± 15 %.
- Air changes: ca. 15 per hr.
- Photoperiod: 12/12.
IN-LIFE DATES: From: March 3, 1982 To: March 29, 1982
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 and 20 ml/kg
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg - Doses:
- 300, 1000, 2500, 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing:
Mortality: daily, a.m. and p.m. on working days.
Signs and Symptoms: daily.
Body weight: on days 1, 7, 14 and at death.
- Necropsy of survivors performed: yes.
Necropsies: Spontaneously dying animals were submitted to a gross necropsy as soon as possible; survivors at the end of the observation period.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- From the body weights, the group means and their standard deviations were calculated.
The LD50 including the 95 % confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39.357-65, 1944)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 004 mg/kg bw
- Based on:
- test mat.
- Remarks:
- API: 55.6%
- 95% CL:
- >= 966 - <= 7 827
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 152 mg/kg bw
- Based on:
- test mat.
- Remarks:
- API: 55.6%
- 95% CL:
- >= 660 - <= 82 457
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 120 mg/kg bw
- Based on:
- test mat.
- Remarks:
- API: 55.6%
- 95% CL:
- >= 1 279 - <= 4 373
- Mortality:
- No deaths occurred at 300 mg/kg bw.
At 1000 mg/kg bw, 1 male and 2 females died within two days.
At 2500 mg/kg bw, 2 males and 2 females died within two days.
At 5000 mg/kg bw, all males and 3 females died on Day 1; one further female died on Day 13. - Clinical signs:
- Only signs of unspecific toxicity were observed at all dose levels, such as, sedation, dyspnoea, exaphthalmos, ruffled fur, curved body position.
- Body weight:
- All surviving animals showed regular body weight development.
- Gross pathology:
- No compound related gross organ changes were observed.
Applicant's summary and conclusion
- Interpretation of results:
- other: classified in Category 4 for acute toxicity according to the CLP Regulation (EC) No. 1272/2008
- Remarks:
- calculated for 100 % AI
- Conclusions:
- LD50 in male rats: 2004 (966-7827) mg/kg bw.
LD50 in female rats: 2152 (660-82457) mg/kg bw.
LD50 in rats of both sexes: 2120(1279-4373) mg/kg bw. - Executive summary:
Upon a acute oral administration and a 14 day post-treatment observation period, the following lethal doses (with 95 % confidence limits) were determined for the test material (purity 55.6 %).
LD50 in male rats: 2004 (966-7827) mg/kg bw.
LD50 in female rats: 2152 (660-82457) mg/kg bw.
LD50 in rats of both sexes: 2120(1279-4373) mg/kg bw.
Signs of unspecitic toxicity were seen at all dose levels.
According to the company standard the test material has a slight acute toxicity when administered orally to the albino rat.
Calculated for 100 % AI, the LD50 lies between 300 and 2000 mg/kg bw, and hence results in classification in Category 4 based on CLP criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
