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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 September 1986 to 17 October 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study was performed prior to OECD guidelines and was not GLP compliant. Test method was an acute oral toxicity test in 5 rats/sex/group that received 400, 500, 640 or 1000 mg/kg test material as a single oral gavage. Sufficient information was available for hazard classification per Annex VI of the CLP criteria.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ANSI/ADA Doc No. 41A (1982)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Lauryl imidazole
IUPAC Name:
Lauryl imidazole
Details on test material:
- Name of test material (as cited in study report): Lauryl imidazole
- Substance type: Pure active substance
- Physical state: Liquid
- Analytical purity: 99%
- Purity test date: 22 July 1986
- Lot/batch No.: Batch 0001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, Cambridgeshire, England
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 200-266g
- Fasting period before study: 4 hours prior to dosing
- Housing: IN groups by sex in metal cages with wire mesh floors
- Diet (e.g. ad libitum): Standard laboratory rodent diet (Labsure LAD1) ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24
- Humidity (%): Mean: 66
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 03 September 1986 To: 17 October 1986

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.12 mL/kg
Doses:
400, 500, 640, or 1000 mg/kg
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: 0.5, 1, 2, 3, 4, 5, and 6 hours after dosing (Day 1) and then at least once daily through Day 15
- Necropsy of survivors performed: macroscopic necropsy performed on all animals
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
ca. 641 mg/kg bw
Based on:
act. ingr.
95% CL:
>= 558 - <= 759
Mortality:
Animal(s) died in the 500 mg/kg (1/5 females), 640 mg/kg (2/5 males and 5/5 females), and 1000 mg/kg (4/5 males, 5/5 females) treated groups from Day 2 to Day 5.
Clinical signs:
other: Piloerection and increased salivation were observed in all rats. Hunched posture was observed in all animals except one male and one female of the 1000 mg/kg group. Clinical signs with dose dependent increases in incidence included: decreased respiratory
Gross pathology:
No gross abnormalities were observed upon macroscopic necropsy.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study (10% mortality at 500 mg/kg and increasing mortality at 1000 mg/kg), the rat oral LD50 is 641 mg/kg with 95% confidence limits of 558 to 759 mg/kg.
Executive summary:

 The acute oral toxicity potential of the test article (yellow liquid, purity 99% CASRN 4303-67-7, batch 0001) was tested in male and female CFY Sprague Dawley rats. The experimental procedure was based on ANSI/ADA Document number 41a 1982. The test article was administered as received via oral gavage. Rats (5/sex/group) received 400, 500, 640, or 1000 mg/kg test article. Clinical observations were recorded at 0.5, 1, 2, 3, 4, 5, and 6 hours after dosing (Day 1) and then at least once daily through Day 15. Body weights were recorded on Day 1, 8, 15 and on the day of death. Surviving animals on Day 15 were euthanatized and received macroscopic necropsy examination. Animal(s) died in the 500 mg/kg (1/5 females), 640 mg/kg (2/5 males and 5/5 females), and 1000 mg/kg (4/5 males, 5/5 females) treated groups from Day 2 to Day 5. Animals that survived to Day 6 survived until the end of the study on Day 15. Animals that died prematurely had congestion of the stomach and pallor of the liver, kidneys, and/or spleen. Body weight losses were recorded for all rats found dead. Piloerection and increased salivation were observed in all rats. Hunched posture was observed in all animals except one male and one female of the 1000 mg/kg group. Clinical signs with dose dependent increases in incidence included: decreased respiratory rate, ptosis, pallor of the extremities, diarrhea, increased lachrymation, and prostration. Lethargy and abnormal gait (waddling) were observed in 3-5 animals/sex in the 400, 640, and 1000 mg/kg dose groups and only 1 female in the 500 mg/kg group. Body weight losses or decreased gains were recorded among surviving male rats of all groups on Day 4 and among surviving female rats on Days 4 and 8. All surviving rats achieved anticipated body weight gains during the second week of the study with the exclusion of one female rat that had slightly decreased gain on Day 15. Terminal necropsies were normal. The oral LD50 with a 95% confidence interval was calculated using probit analysis by a log transformation of the dose relative to percent mortality. Based on the results of this study (10% mortality at 500 mg/kg and increasing up to 90% mortality at 1000 mg/kg), the rat oral LD50 is 641 mg/kg with 95% confidence limits of 558 to 759 mg/kg.