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Acute Toxicity: oral

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acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

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:
3-(2-hydroxyethyl)-p-phenylenediammonium sulphate
EC Number:
EC Name:
3-(2-hydroxyethyl)-p-phenylenediammonium sulphate
Cas Number:
Molecular formula:
2-(2,5-Diaminophenyl)ethanol sulfate (1:1)
Specific details on test material used for the study:
Trade name : Betoxol
Purity : >98%

Test animals

other: Him : OFl
Details on test animals or test system and environmental conditions:
Number in the preliminary study : Four females
Number in the main study : Twenty five males and twenty five females
Age : Approx 8 weeks at the time of administration

Administration / exposure

Route of administration:
oral: gavage
other: Distilled water
20, 36, 63, 112, 200 mg/kg bw
No. of animals per sex per dose:
Ten (5 males and 5 females) per dose group
Control animals:
Details on study design:
Justification for the selection of the doses : In a preliminary test 4/4 animals (2 per dose) died at doses of 200 and 2000 mg/kg bw. Based on this information, 200 mg/kg bw was chosen as the highest dose. The lowest dose was 10% of the highest dose. The other doses were interpolated. Behaviour, reactions and physical signs of the animals were observed 1, 10, 30 min, 1, 2, 4 and 6 hours after administration and then at least once a day for 2 weeks. Findings were recorded. Body weight was determined before administration, 7 days and 14 days post administration. All animals that died were dissected and examined macroscopically in an attempt to identify the target organs. All surviving animals were sacrificed by CO2 14 days post administration and examined macroscopically.
LD50 and 95 CL were calculated according to Thompson (Bact. Rev. 11 (1947)).

Results and discussion

Effect levels
Dose descriptor:
Effect level:
80 mg/kg bw
Based on:
test mat.
95% CL:
>= 71 - <= 89
1/10 animals in group 3 (63 mg/kg bw), 10/10 in group 4 (112 mg/kg bw) and 10/10 in group 5 (200 mg/kg bw) died early. Death occurred within 2 hours (males) and 1 hour (females) after test substance administration in the highest dose group 5 (200 mg/kg bw), within 6 hours (males) and 4 days (females) in group 4 (112 mg/kg bw), within 4 hours (one male) in group 3 (63 mg/kg bw).
Clinical signs:
other: Some unspecific signs of general malaise, decreased motor activities, ruffled fur, closed eyes, hunched posture, decreased muscular tension, unconsciousness were noted during the observation time in all animals. In some animals ataxia, dyspnoea or minor c
Gross pathology:
At post mortem examination of the early deaths alterations of the small intestine, discoloured liver, small spleen and lung oedema were observed. Post mortem findings indicated an irritative effect to small intestine which was deemed to be the cause of death and additionally a hepatotoxic effect. All surviving animals and seven of the early died animals were normal at post mortem examination. In most of the other early died animals an abundant yellow aqueous content in the small intestine was observed. In some of these anmals pale yellow liver, white foci on the liver or small spleen were observed. In one of the early died animals an aqueous bloody content in the small intestine, in another oedema of the lungs were observed. Shock due to severe gastrointestinal irritation is assumed to be the cause of death. Liver changes indicate a hepatotoxic effect. Lung oedema is attributed to agonal circulatory breakdown. Small spleen may be caused by haemodynamic disorder or blood loss after intestinal irritation. Chromodacryorrhoeais regarded as a unspecific sign of reduced well being.
Other findings:
At terminal necropsy of the surviving animals no changes were noted. All animals were normal.

Any other information on results incl. tables

The LD50 (oral) calculated for both sexes combined was determined to be 80mg/kg bw in mice. The confidence limits (95%) are 71 and 89 mg/kg bw. No pronounced differences in the LD50 values between males (75 mg/kg bw) and females (84 mg/kg bw) were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Under the experimental conditions of the study, the LD50 was determined to be 80 mg/kg bw (71-89 mg/kg bw 95% CI) for both sexes combined