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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
07. Dec. - 23. Dec. 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (no analytical purity reported)
Justification for type of information:
refer to analogue justification provided in IUCLID section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
no analytical purity reported
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
no analytical purity reported
GLP compliance:
yes (incl. QA statement)
Remarks:
Safepharm Laboratories Limited, Derby, UK
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
131459-39-7
Cas Number:
131459-39-7
IUPAC Name:
131459-39-7

Test animals

Species:
rat
Strain:
other: Sprague-Dawley CD (Crl:CD® (SD) IGS BR)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 234 - 237g (males), 215 - 220g (females)
- Housing: in groups of up to 3 by sex in solid-floor polypropylene cages
- Diet: rat and mouse Diet No.1, Special Diets Services Limited, Witham, Essex, UK, ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21
- Humidity (%): 37 - 67
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.09 mL/kg

DOSAGE PREPARATION: The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.

CLASS METHOD
- Rationale for the selection of the starting dose: The available information suggested the starting dose.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for death or overt signs of toxicity 0.5; 1; 2 and 4 hours after dosing and subsequently once daily; individual body weights were determined prior to dosing, on day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy and histopathological examination revealed no substance-related finding.

Any other information on results incl. tables

Table 1: Bodyweight gain

Dose level   Bodyweight [g] at Day
mg/kg bw female 0 7 14
2000 1-0 220 259 280
1-1 217 251 258
1-2 215 249 272
male      
2-0 235 307 348
2-1 237 300 343
2-2 234 298 343

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified