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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:
22 July 2005 to 23 November 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Fully Guideline- and GLP-compliant

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VP Resin 835 A / Kat.
- Molecular formula: C20H28O2
- Physical state: solid
- Lot/batch No.: Test number 6013
- Expiration date of the lot/batch: 10 July 2006
- Stability under test conditions: stable
- Storage condition of test material: ambient temperature, in the dark, may be used under light

Test animals

Species:
rat
Strain:
other: Crl:CD(SD)IGS BR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 97633 Sulfeld, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: means of 183.3 g (males) and 187.0 g (females)
- Fasting period before study: over night
- Housing: single caging, Makrolon type III, wire mesh lids
- Diet (e.g. ad libitum): Altromin 1324 forte, gamma-irradiated, ad lib.
- Water (e.g. ad libitum): tap water, ad lib.
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22.1 °C
- Humidity (%): average of 71.6 %
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 17 August 2005 To: 1 September 2005

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.1 % aqueous solution of CMC (high viscosity, Sigma) plus Tween 80 (polyoxyethylensorbitanmonooleate)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: test substance not soluble in water. CMC plus Tween 80 is a common vehicle for acute oral testing.
- Lot/batch no. (if required): CMC: item No. C-5013, Lot No. 98H0328, Sigma; Tween 80: article 822187, Merck


MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: requested by the sponsor
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing:
Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day for a total of 2 weeks. Observations included but were not limited to changes in skin, fur, eyes, the occurrence of secretions and excretions, autonomic activity, changes in gait, posture and the presence of convulsions.

Body weights were determined before administration and 7 and 14days p.a.
Body weight gain was calculated for each week of the study, i.e. between 0 and 7 days p.a. and between 7 and 14 days p.a.

- Necropsy of survivors performed: yes
Statistics:
No statistics performed

Results and discussion

Preliminary study:
n.a.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortality
Clinical signs:
All animals were normal during the entire observation period.
Body weight:
All animals gained weight in both weeks p.a.
Gross pathology:
All animals were normal at the necropsy 14 days p.a.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No toxic effects of the test substance were noted by signs in life and post mortem at a dose of 2000 mg test substance per kg body weight. No mortality occurred.
Executive summary:

The aim of the study was to investigate acute toxic effects of the test substance after a single peroral administration to rats.

Methods and investigations were performed in conformance with the OECD-Guideline 423,and theDirective2004/73/EC, method B.1 tris.

"VP Resin 835 A / Kat."was administered once as a suspension in an aqueous solution of 0.1 % Na-carboxymethylcellulose plus 0.1 % Tween 80, given orally via gavage to female Crl:CD(SD)IGS BR rats. The dosing was performed sequentially to groups of 3 animals per step using a starting dose of 2000 mg per kg body weight. The dose volume was 20 mL per kg body weight for all groups.

Investigations

·      Body weights: before administration, 7 and 14 days after the administration (p.a.).

·      Clinical observations: at least once per day.

·      Necropsy: The animals were sacrificed and necropsied 14 days p.a.

Results

Dose
(mg/kg)

Step No.

No. of animals

Prominent findings

exposed

affected

deceased

in life

post mortem

2000

1

3

0

0

none

none

2000

2

3

0

0

none

none

 

Presence of signs in life

no signs

Full recovery of the survivors

not applicable

Body weights

all animals gained weight in both weeks p.a.

Findings in life and post mortem indicate

no toxic effects present

LD50, oral

> 2000 mg/kg body weight

 

 

According to Commission Directive 2001/59/EC"VP Resin 835 A / Kat." does not require classification for acute oral toxicity.