Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From May 06 to May 27, 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test conducted according to internationally accepted Guideline and in according to the GLP Principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: Nulliparous abd non pregnant female
- Source: Harlan italy Srl
- Age at study initiation: 6 - 7 weeks old rats
- Weight at study initiation: in the range of 165 and 171 g
- Housing: 3 animals per cages during the study 5 animals per cages during acclimatisation (Clear polysulphone H-Temp solid bottomed cages)
- Cage control: Daily inspected and changed as necessary (at least 3 times/week)
- Diet (e.g. ad libitum): ad libitum (laboratory rodent diet: 4RF 18, Mucedola Srl)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
- Veterinary health check: During acclimation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 15 %
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.5 % in aqueous solution of carboxymethylcellulose
- Amount of vehicle (if gavage): 10 ml/kg bw
Doses:
2000 mg/kg bw
A first group of 3 female animals was dosed at a level of 2000 mg/kg body weight (Group 1, Step 1). Mortality did not occur. A second group, similarly composed, was then dosed at the same dose level (Group 2, Step 2). No mortality occurred. No further doses were investigated since the objective of the study had been achieved.
No. of animals per sex per dose:
3 female per tested dose per group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No abnormalities were observed.
Body weight:
No abnormalities were observed.
Gross pathology:
No abnormalities were observed.

Any other information on results incl. tables

Mortality and clinical signs

No mortality occurred and no clinical signs were observed in the first group of animals initially dosed at 2000 mg/kg bw (Group 1, Step 1) and in the further group of 3 females dosed at the same dose level (Group 2, Step 2).

 

Body weight

Changes in body weight observed during the study were within the expected range for this strain and age of animals.

 

Necropsy

No abnormalities were observed at necropsy examination performed on all animals dosed at 2000 mg/kg (Groups 1 and 2) at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information acccording to the CLP Regulation (EC n. 1272/2008) Criteria used for interpretation of results: EU
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

Method

The test has been conducted according to the EU method B.1 tris, corresponding to the OECD Guideline 423.

The acute toxicity of the substance was investigated following a single oral administration (10 ml/kg in 0.5 % aqueous solution of carboxymethylcellulose) to the Sprague Dawley rat followed by a 14-day observation period.

 

Observations

No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000 mg/kg bw. These results indicate that the test item, AP 1300 S, did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg bw.

 

Results

The lack of mortality demonstrates the acute toxicity expected (LD50) to be greater than 2000 mg/kg bw.