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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:
Between 1965-03-04 and 1965-06-10
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Comparable to guideline study with acceptable restrictions: no data on mortality / dose group and how LD50 was calculated, only male animals used. Evidence from repeated dose studies indicates that there is no significant difference in sensitivity between males and females and that the acute oral toxicity is not higher by an order of magnitude or more (chapter 7.5.1 entry # 1: 13 week LOAEL ca. 150 mg/g bw/day for males and females).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
see Test Conditions
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Isophorone diamine, no data on purity

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
- Weight at study initiation: 110-130 g
- Fasting period before study: since day before

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
- Concentration in vehicle: 50 % (v/v)
- Amount of preparation: 0.5, 1.0, 1.5, 2.0 and 2.5 ml per kg b.w.
Doses:
50 % v/v solution in water, 0.5, 1.0, 1.5, 2.0 and 2.5 ml per kg b.w.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Post dose observation period: 14 days
Urine control for proteine
EXAMINATIONS: organs not listed
Statistics:
no data

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
1 030 mg/kg bw
Mortality:
Time of death: after 12 to 18 hours in lateral position, no data on mortality / dose group
Clinical signs:
1 hour after dosing, animals showed restlessness, thirst, rough fur and tiredness.
Body weight:
no data
Gross pathology:
irriation of the intestinal mucosa, with a few animals showing a slight increase in kidney weight and protein in the urine
POTENTIAL TARGET ORGANS: kidney
Other findings:
no other findings

Any other information on results incl. tables

no further remarks

Applicant's summary and conclusion

Conclusions:
The LD50 value of acute oral toxicity in male rats of the test substance isophorone diamine was determined to be 1030 mg/kg bw.
Executive summary:

The acute oral toxicity LD50 value in male Sprague-Dawley rats was determined to be 1030 mg/kg b.w.. Doses of 0.5, 1.0, 1.5, 2.0, or 2.5 ml/kg bw of a 50 % v/v solution in water were applied by gavage followed by a post dose observation period of 14 days.Clinical signs observed from 1 hour after dosing were restlessness, thirst, rough fur and tiredness. At necropsy, irritation of the intestinal mucosa was observed. A few animals (no further data) showed a slight increase in kidney weight and protein in the urine, which may indicate that the kidney is a target organ.