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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 June 2001 to 05 July 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not conducted in compliance with GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
no
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Laurylmercaptobutyronitril
IUPAC Name:
Laurylmercaptobutyronitril
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): Laurylmercaptobutyronitril
- Substance type: Mono-constituent
- Physical state: Liquid
- Analytical purity: 99%
- Purity test date: No data
- Lot/batch No.: P 5889001
- Expiration date of the lot/batch: 01 April 2002
- Storage condition of test material: At room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding Division
- Age at study initiation: Males: 8 weeks, Females: 10 weeks
- Weight at study initiation: Males: 193.6-210.5 g, Females: 183.1-185.5 g
- Fasting period before study: 16-20 hours
- Housing: 3 animals per sex per cage
- Diet (e.g. ad libitum): Pelleted standard Provimi Kilba 3433 rat maintenance diet (batch no. 07/00) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 12 June 2001 To: 05 July 2001

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Remarks:
Roth AG, Batch 022938667
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): Batch 022938667
- Purity: No data
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs were recorded four times per day on Day 1, and once daily thereafter. Body weights were recorded on Day 1 prior to administration, and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
dissolved
Mortality:
All animals survived until the end of the study period.
Clinical signs:
No clinical signs were observed during the course of the study.
Body weight:
The body weight of the test animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the oral LD50 of the test article is greater than 2000 mg/kg body weight.
Executive summary:

The acute oral toxicity potential of the test article was assessed in male and female Wistar rats. The study was not conducted in compliance with GLP regulations. The test method was based on OECD 423 (1996) and Directive 96/54/EEC, B.1 tris "Acute Oral Toxicity-Acute Toxic Class Method" (1996). The test article was suspended in vehicle (corn oil) at a concentration of 0.2 g/mL and administered by oral gavage to 3 rats per sex at a dose volume of 10 mL/kg body weight, for an administered dose of 2000 mg/kg body weight. Clinical signs (four times on Day 1, daily thereafter) and body weights (Day 1, 8, 15) were recorded. All animals were subjected to gross necropsy on Day 15 post-dose. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the test animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. Based on the results of the study, the oral LD50 of the test article is greater than 2000 mg/kg body weight.

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