Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19 May 2009 to 03 June 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Compliant to OECD 423 and GLP guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

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
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: Triazin UV-Absorber

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Species and strain: CRL:(WI)BR rats
- Source: Charles River (Europe) Laboratories Inc. Toxi Coop Ltd., 1103 Budapest, Cserkesz u. 90.
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: 214 g to 228 g
- Fasting period before study: over night until 3 hours post treatment
- Housing: Group caging (3 animals/cage)
- Diet: ssniff® SM R/M-Z+H ad libitum
- Water: tap water ad libitum
- Acclimation period: 20 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 19 May 2009 To: 03 June 2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: solubiltity in vehicle
- Lot/batch no. (if required): 1421464



CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: test item was considered to have low toxicity based on experience with similar compounds
Doses:
2000 mg/kg
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Clinical signs: 30 minutes, 1, 2, 3, 4 and 6 hours after dosing on Day 0 and daily for 14 days thereafter
- Body weight: weekly
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no deaths occurred
Clinical signs:
no adverse effects
Body weight:
no adverse effects
Gross pathology:
no findings

Any other information on results incl. tables

Mortality

Treatment group:

1

2

Dose (mg/kg bw):

2000

2000

Number of animals treated:

3

3

Mortality:

0/3

0/3

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item Triazin UV-Absorber was above 2000 mg/kg bw in female CRL:(WI) BR rats.
Triazin UV-Absorber was ranked into Category 5 of the Globally Harmonized Classification System.
Executive summary:

The single-dose oral toxicity of Triazin UV-Absorber was performed according to the acute toxic class method (OECD 423, OPPTS 870.1100 and Commission Regulation (EC) No 440/2008, B.1 tris (L 142, 30 May 2008)) in CRL: (WI) BR rats. The study was performed at a dose level of 2000 mg/kg body weight (bw). Two groups of three female CRL: (WI) BR Wistar rats (about 8 weeks of age) were treated with a solution of Triazin UV-Absorber in Polyethylene-glycol 400 (PEG) at 2000 mg/kg bw by oral gavage (Groups 1 and 2). Initially, three females (Group 1) were treated at 2000 mg/kg bw. As no mortality occurred in this dose group, a confirmatory treatment according to OECD 423 was performed on 3 further females at the same dose level (2000 mg/kg bw). Rats were maintained without compound administration for a 2-week observation period after the day of dosing. As no mortality was observed in the second dose group, no further treatment was needed. A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Triazin UV-Absorber was administered at a concentration of 200 mg/mL (Groups 1 and 2) prepared in PEG400 with a treatment volume of 10 mL/kg bw. Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Food was made available again 3 hours after the treatment. Bodyweight was measured on Days -1, 0 and 7 and before necropsy. Gross necropsy was performed on all animals (Day 14).

Mortality

Triazin UV-Absorber did not cause mortality at 2000 mg/kg bw.

Clinical observations

No clinical signs were observed after the treatment with the test item or during the 14 day observation period.

Bodyweight and Bodyweight gain

Bodyweight gains of Triazin UV-Absorber treated animals during the study showed no indication of a test item-related effect.

Macroscopic Findings

A single oral gavage of Triazin UV-Absorber to the CRL:(WI) BR rat at a dose level of 2000 mg/kg bw, followed by a 14 day observation period, was not associated with any test item-related gross findings.

Under the conditions of this study, the acute oral median lethal dose (LD50) of the test item Triazin UV-Absorber was greater than 2000 mg/kg bw in female CRL:(WI) BR rats. Triazin UV-Absorber was ranked into Category 5 of the Globally Harmonized Classification System.