Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
17th December 2001
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
Species and strain: Han:WIST rats
Source: TOXI COOP ZRT.
Cserkesz u. 90.
1103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The Wistar rats as a rodent is one of the standard species
of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8-9 weeks old in first, second, third and
fourth step
Body weight range
at starting (first step): 140 - 144 g
Body weight range
at starting (second step): 137 - 144 g
Body weight range
at starting (third step): 149 - 152 g
Body weight range
at starting (fourth step): 133 - 143 g
Acclimatization time: 5 days in first step, 6 days in second step, 7 days in third
step and 8 days in fourth step

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Aqua purificata
Doses:
300 mg/kg bw and 2000 mg/kg bw
No. of animals per sex per dose:
The acute toxic class method was carried out involving a stepwise procedure with the use of
300 mg/kg bw as the starting dose in three female rats. No animal died in first step, so further
three female rats were treated with the same (300 mg/kg bw) dose. No animal died in second
step, so further three female rats were treated with the 2000 mg/kg bw dose. No animal died in
third step, so further three female rats were treated with the same (2000 mg/kg bw) dose. No
animal died in fourth step, too. Test was finished, because the stopping criteria of Annex 2c of
OECD Guideline No. 423 (presented in Appendix VII) was met.
Control animals:
not specified

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No death occurred at 300 mg/kg bw single oral dose of Ammonium Adipate. All female rats
in step 1 and step 2 survived until the end of the 14-day observation period.
No death occurred at 2000 mg/kg bw single oral dose of test item. All female rats in step 3
and step 4 survived until the end of the 14-day observation period
Clinical signs:
In group 1 treated with 300 mg/kg bw dose no treatment related symptoms were observed
throughout the 14-day post-treatment period.
In group 2 treated with 300 mg/kg bw dose no treatment related symptoms were observed
throughout the 14-day post-treatment period.
In group 3 treated with 2000 mg/kg bw dose no treatment related symptoms were observed
throughout the 14-day post-treatment period.
In group 4 treated with 2000 mg/kg bw dose no treatment related symptoms were observed
throughout the 14-day post-treatment period.
Body weight:
The mean body weight of animals treated with 300 or 2000 mg/kg bw dose corresponded to
their species and age throughout the study.
Gross pathology:
All animals treated with 300 mg/kg bw dose survived until the scheduled necropsy on
Day 15 and all animals treated with 2000 mg/kg bw dose survived until the scheduled
necropsy on Day 15.
Slight hydrometra was detected in animal No.: 3039 of group 1 (300 mg/kg bw) and in
animal No.: 3041 of group 2 (300 mg/kg bw). Severe hydrometra was found in two animals
(No.: 3048, 3049) of group 4 (2000 mg/kg bw) Hydrometra is a physiological finding and
related to the estrous cycle of the animal.
No pathological changes were found related to the effect of the test item during the
macroscopic examination of animals treated with 300 or 2000 mg/kg bw dose.
Other findings:
No death occurred after the single 2000 or 300 mg/kg bw oral dose of Ammonium Adipate.
There were no toxic clinical signs and any related to the effect of the test item found in body
weights and body weight gains during the study in both doses.
Autopsy revealed no treatment related pathological changes in both doses.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD50 is above 5000 mg/kg bw. It is not classifed as Acute toxicity (oral).
Executive summary:

LD50 is above 5000 mg/kg bw.

No death occurred after the single 2000 or 300 mg/kg bw oral dose of Ammonium Adipate.
There were no toxic clinical signs and any related to the effect of the test item found in body weights and body weight gains during the study in both doses.
Autopsy revealed no treatment related pathological changes in both doses.