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Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992-01-07 to 1992-02-25
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report

Materials and methods

Test guideline
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:

Test animals

Details on test animals or test system and environmental conditions:
- Source:Charles River (UK) Limited,
- Strain:Sprague-Dawley Cr1:CD (SD)
- Sex. male and female
- Age: approximately five to eight weeks old
- Weight at study initiation: Males:126 - 148 g, females:120 - 142 g
- Housing:group-housed, up to 5 animals of the same sex and dose group/cage
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet, Services Limited, Witham, Essex, U.K.)K,
ad libitum, with the exception of an overnight fast immediately before dosing and for approximately two hours after dosing,
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days

- Temperature (°C): 19 - 22 °C
- Humidity (%): 52 - 63 %
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours daily

Administration / exposure

Route of administration:
oral: gavage
unchanged (no vehicle)
Details on oral exposure:
For the purpose of the study the test material was used as supplied. The specific gravit was determined by Safepharm Laboratories Limited and used to calculate the appropriate dose volumes for the required dose levels.

- Doses: 1333, 2000, and 3000 mg/kg bw
- Doses per time period: single dose by gavage
- Volume administered or concentration: 1.38-3.10 ml/kg bw
1333, 2000, and 3000 mg/kg bw
No. of animals per sex per dose:
Control animals:
Details on study design:
- Post dose observation period: 14 days

- clinical signs and mortality: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days
- body weight: day 0, 7 and 14 (or at death)
- macroscopy
STATISTICAL METHOD: - Thompson, 1947

Results and discussion

Preliminary study:
see table above
Animals treated with 2000 mg/kg were found dead one day after dosing. Common signs of systemic toxicity noted were hunched posture, lethargy and ptosis with additional signs of decreased
respiratory rate.
Based on this information, dose levels of 1333, 2000 and 3000 mg/kg bodyweight were selected for the main study.
Effect levels
Key result
Dose descriptor:
Effect level:
2 169 mg/kg bw
Based on:
test mat.
95% CL:
> 1 916 - < 2 455
- Number of deaths at each dose (time of death): at 1333, 2000 and 3000 mg/kg: 0, 1 male (day 4)/2 females (day 1), 10 (day 1)
Clinical signs:
other: - At 1333 mg/kg hunched posture; - at 2000 mg/kg lethargy and/or hunched posture and decreased respiratory rate and labored breathing in the male that died. All animals were recovered by day 3; - at 3000 mg/kg lethargy, comatosis, ptosis, ataxia, and hu
Gross pathology:
- At 1333 mg/kg large amounts of white foci scattered over nog-glandular epithelium of stomach;
- At 2000 mg/kg (in animals that died) and 3000 mg/kg hemorrhagic and red stained lungs, dark or patchy pallored liver, dark colored kidneys, hemorrhagic gastrous mucosa and non-glandular stomach epithelium, gaseous distension or severe hemorrhage of small and large intestine; surviving animals at 2000 mg/kg displayed foci on stomach epithelium.
Other findings:
no other findings

Any other information on results incl. tables

Combined sexes 2169 (1916-2455) mg/kg bw
Males: 2259 (1920-2656) mg/kg bw
Females: 2083 (1707-2540) mg/kg bw

Applicant's summary and conclusion

The oral LD50 for test item in rats was 2169 mg/kg body weight. Test item is practically non-toxic following a single oral exposure.
Executive summary:

The study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals (1987) No. 401 "Acute Oral Toxicity" referenced as Method B1 i n Commission Directive 84/449/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (as adapted to technical progress by Commission Directive 83/467/EEC).

The test system was chosen because the rat has been shown to be a suitable model for this type of study and is recommended in the test method. The results of the study are believed to be of value in predicting the likely toxicity of the test material to man.


Groups of ten Sprague-Dawley rats (five male and five female) were orally administered undiluted test item at dose levels of 1333, 2000 and 3000 mg/kg body weight. 

Surviving animals were observed daily post-dose for 14 days. 

All animals in the low dose group survived. Three out of ten animals in the mid-dose group died. All animals in the high-dose group died. 

All surviving animals appeared normal within three days or less of dosing, gained weight, and the only findings seen at necropsy in the survivors were abnormalities of the non-glandular stomach epithelium. 

Since this material is corrosive, the stomach findings were not unusual. 

The oral LD50 for test item in rats was 2169 mg/kg body weight.