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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 days
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not according to OECD guidelines (study in 1978), but very well documented and structural approach.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Principles of method if other than guideline:
Test system: Albino rat, Wistar strain (Institute colony); 5 males and 5 females per group, exposed to single doses of 5.0, 6.0, 7.2, 8.6, or 10.4 ml/kg bw, given by gavage, as a 10% (w/v) suspension in propylene glycol.
The LD50 was calculated according to the method of Weil (Biometrics 8 (1952) 249-263).
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A 200 g sample of the test material was received from the principal in March 1978. It was a colourless solid with a melting-point between 25 and 30 degrees Celcius

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Yong adult albino rats (Wistar-derived) from the Institute's colony were used. The body weights of males varied from 205 to 307 g, those of females from 93 to 145 g.
The rats were housed in groups of five in screen-bottomed stainless steel cages in a well-ventilated room, maintained at 23-25 degrees Celsius. Before dosing the rats fasted overnight.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
propylene glycol
Details on oral exposure:
The test material was giving by gavage, as a 10 per cent (w/v) suspension in propylene glycol.
After treatment the rats received stock diet and tap water ad libitum.
Doses:
5.0, 6.0, 7.2, 8.6, and 10.4 ml/kg bw
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Details on study design:
After treatment the rats were observed for signs of intoxication during a 14-day period, after which autopsies were carried out on the survivors.
Statistics:
The LD50 was calculated according to the method of Weil (Biometrics 8 (1952), pp 249-263.

Results and discussion

Preliminary study:
DAB: LD50 (rat, oral): 740 mg/kg body weight (95% reliability interval: 650 - 850 mg/kg bw), both sexes
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
740 mg/kg bw
95% CL:
> 650 - < 850
Clinical signs:
Within one hour of treatment, the rats showed signs of sluggishness and abdominal discomfort.
Later on unconsciousness was frequently observed.
Black coloured faeces and severe diarrhoea were observed during the first three post-treatment days.
Deaths occured between 2 and 42 hours after dosing.
After 3 days the survivors recovered gradually and looked quite healthy again at the end of the observation period.
Gross pathology:
Macroscopic examination of the survivors at autopsy revealed no treatment-related gross alterations.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
From the mortality figures the LD50 of 1,4-diaminobutane was calculated to be 0.74 g/kg bw with 0.65 and 0.85 at the 95% confidence limits.
Therefore, the test product can be classified as slightly toxic.
Based on these results and according to the EEC criteria for classification and labeling requirements for dangerous substances and preparations (EEC Directive 91/325/EEC, amendment to annex VI of the EEC Directive 67/548/EEC), DAB is classified as harmful, Xn, R22 Harmful if swallowed.
Executive summary:

Oral gavage study, Wistar albino rats (5 males, 5 females).

LD50 (oral, rats) = 740 mg/kg bw (95% confidence limits: 650 - 850 mg/kg bw).

1,4 -Diaminobutane was classified as slightly toxic;

DAB is classified as harmful, Xn, R22 Harmful if swallowed (EEC Directive 91/325/EEC, amendment to annex VI of the EEC Directive 67/548/EEC).

CLP: Category 4; H302 Harmfull if swallowed