Registration Dossier

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:
August 3rd to 16th, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Reliability of the original study is 1
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Study design is based on OECD Guideline 401 (1987). Study design appears to follow OECD Guideline 423 (2001) with limit test at 5000 mg/kg bw. Contains sufficient detail to suggest GLP-like characteristics, but no statement of certification (reasonably thorough description of authors, dates, design, results and interpretation).
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif:RAIf(SPF), F3-crosses of RII 1/Tif X RII 2/Tif
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Ltd., Tierfarm, Sisseln, Switzerland.
- Age at study initiation: 7 - 8 weeks.
- Weight at study initiation: 163 - 184 g.
- Fasting period before study: overnight prior to dosing.
- Housing: groups of 5 in Macrolon cages type 3 with standardized soft wood bedding (Societe Parisienne des sciures, Pantin).
- Diet: ad libitum, NAFAG No. 890, NAFAG AG, Gossau, SG (Switzerland).
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C.
- Humidity: 55 ± 15 %.
- Air changes: 15 per hr
- Photoperiod: 12hrs dark / 12hrs light.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: CMPS80
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw
Doses:
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: daily (mortality and symptoms); on days 1, 7, 14, and at death (weight).
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs, body weight.
Statistics:
From the body weights, the group means and their standard deviations were calculated.
Where feasable, 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:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Mortality:
None
Clinical signs:
Dispnea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6. The animals recovered within 11 days.
Body weight:
No significant bodyweight changes were observed
Gross pathology:
No compound related gross organ changes were observed

Applicant's summary and conclusion

Interpretation of results:
other: not classified as harmful/toxic according to the CLP Regulation (EC) No.1272/2008
Conclusions:
LD50 (male, female rats) > 5000 mg/kg bw
Executive summary:

The acute toxicity of the test material to rats was evaluated in a limit test according to the OECD Guideline 401. Five male and five female rats were administered with the substance at 5000 mg/kg bw. The rats were observed daily for mortality and clinical signs and were weighed on days 1, 7, 14, and at death. The survived animals were necropsied.

No compound related gross organ changes an no significant bodyweight changes were observed. Dispnea from day 1 to day 10; ruffled fur from day 1 to day 9; body position-curved from day 1 to 6 was observed. The animals recovered within 11 days.

LD50> 5000 mg/kg bw.