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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 May 1980 - 25 July 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride
EC Number:
303-085-5
EC Name:
2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride
Cas Number:
94158-14-2
Molecular formula:
C9H11NO3.ClH
IUPAC Name:
2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride
Test material form:
solid: particulate/powder
Details on test material:
beige, cryst. powder

Test animals

Species:
other: rat and mouse
Strain:
other: Wistar (rats) and CF-1 (mice)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 10 % gum arabic solution
Details on oral exposure:
The test material was applied directly into the stomach using a stomach tube. The test substance was suspended to 10% in a 10% gum arabic solution.
Doses:
1000, 1500, 2000 and 2500 mg/kg bw (rats)
500, 750, 1000 and 1250 mg/kg bw (mice)
No. of animals per sex per dose:
5 per sex and dose (rats)
10 females per dose (mice)
Control animals:
not specified
Details on study design:
Mortality and clinical signs were checked daily throughout the 14-day observation period. Body weights were recorded and all animals were submitted to a gross necropsy at the end of the observation period.
Statistics:
Based on the observed mortality rates, the LD50 figures were calculated by the method of Spearman-Kärber.

Results and discussion

Preliminary study:
In a pre-test, the mean lethal dose was determined in 5 male and 5 female Wistar rats, as well as in 10 female CF1 mice by administering doses of 2500 mg/kg bw (rats) and 500 mg/kg bw (mice). All rats died within 24 and 48 hours, but none of the mice. The doses for the main experiment were chosen based on these results.
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Remarks:
rat
Effect level:
1 650 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Remarks:
rat
Effect level:
1 550 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD50
Remarks:
mouse
Effect level:
850 mg/kg bw
Based on:
test mat.
Mortality:
Animals died within 2 - 72 hours after substance administration. Table 1 summarises the mortality rates for the different groups.
Clinical signs:
Clinical signs of toxicity like reduced activity, staggering and piloerection were noted within the first few hours after substance administration.
Gross pathology:
No macroscopic organ changes/damages were noted.

Any other information on results incl. tables

Species

(died/treated)

Dose level [mg/kg bw]

500 

 750

 1000

 1250

 1500

 2000

 2500

mice (female)

0/10

5/10

6/10

10/10

n.t.

n.t.

n.t.

rats (female)

n.t.

n.t.

0/5

n.t.

3/5

4/5

5/5

rats (male)

n.t.

n.t.

0/5

n.t.

2/5

4/5

5/5

Table 1: n.t. = not tested

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The above described study allows a formally valid classification in terms of the acute oral toxicity of the test material. According to the results obtained and regulation (EG) No 1272/2008 (CLP), the test material has to be classified as "H302 : Harmful if swallowed".
Although no analytical data of the test batch were available and although the study was not performed in compliance with GLP, the results are considered sufficiently reliable to evaluate the acute oral toxicity of the test marerial. A repetition of an animal test for hazard identification purposes is not justified.
Executive summary:

The test substance suspended in a 10 % gummi arabicum solution was administered once by oral gavage of 4 different doses from 1000 to 2500 mg/kg bw to Wistar rats and from 500 to 1250 mg/kg bw to female CF1 mice. Mortality and clinical signs were checked daily throughout the 14-day observation period. Body weights were recorded and all animals were submitted to a gross necropsy at the end of the observation period. In a pre-test, the mean lethal dose was determined in 5 male and 5 female Wistar rats, as well as in 10 female CF1 mice by administering doses of 2500 mg/kg bw (rats) and 500 mg/kg bw (mice). All rats died within 24 and 48 hours, but none of the mice. The doses for the main experiment were chosen based on these results. In the main experiment, mortality and clinical signs of toxicity like reduced activity, staggering and piloerection were noted within the first few hours after substance administration. Based on the observed mortality rates, the following LD50 figures were calculated by the method of Spearman-Kärber: 

LD50 rat (female):     1550 mg/kg bw

LD50 rat (male):        1650 mg/kg bw

LD50 mouse (female): 850 mg/kg bw

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