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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
PACM 48 is a solid material.
Isomer content: 48% trans-trans

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 10% ethanol and corn oil
Doses:
- males: 100, 250, 500, 562, 708, 1000 mg/kg
- females: 100, 250, 398, 500, 631 mg/kg
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
480 mg/kg bw
Based on:
test mat.
95% CL:
> 360 - < 650
Sex:
female
Dose descriptor:
LD50
Effect level:
350 mg/kg bw
Based on:
test mat.
95% CL:
> 260 - < 470
Sex:
male/female
Dose descriptor:
LD50
Effect level:
380 mg/kg bw
Based on:
test mat.
95% CL:
> 270 - < 550
Mortality:
- males: 100, 250, 500, 562, 708, 1000 mg/kg. All deaths on day 1.
- females: 100, 250, 398, 500, 631 mg/kg. All deaths on day 1, except for 1 female given 500 mg/kg on day 2 and 1 female given 631 mg/kg on day 7
Clinical signs:
Males:
100 and 250 mg/kg : ruffled appearance on day 1
500 mg/kg: ruffled appearance and (dark) nasal staining
562 mg/kg: ruffled appearance, piloerection, genital staining, convulsions, stained body, dark nasal staining, muzzle staining and/or lethargy during the observation period
708 mg/kg: ruffled appearance on day 1
1000 mg/kg: all animals appeared comatose and died on day 1

Females:
100 and 250 mg/kg: ruffled appearance on day 1
398 mg/kg: gasping immediately after dosing, ruffled appearance, lethargy and/or piloerection between days 1 and 8
500 mg/kg: ruffled appearance, lethargy and/or dark oral and nasal staining between days 1 and 8
631 mg/kg: lethargy and ruffled appearance were noted immediately after dosing
Body weight:
Body weight gain decreased in males at 562 mg/kg. A decreased body weight gain was noted in females at 250, 500 and 562 mg/kg.
Gross pathology:
No treatment-related macroscopic findings were noted in the surviving animals. In animals found dead the following observations were made: signs of irritated stomach, dark liquid in the stomach and lower gastrointestinal tract, pale lungs and kidneys, pale liver and/or hemorrhagic lungs.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information LD50 is between 300 and 2000 mg/kg bw. Criteria used for interpretation of results: EU
Conclusions:
The LD50 of 4-4’-methylenedicyclohexanamine by oral gavage to Sprague-Dawley rats is 380 mg/kg bw.