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:
other: GLP Guidance study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: granule
Details on test material:
- Name of test material (as cited in study report): 1,2,3-Benzotriazole-REACH 01

- Physical state: solid, granule
- Analytical purity: 99.87 %
- Lot/batch No.: 111254/112649
- Expiration date of the lot/batch: Nov 2012
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier
- Age at study initiation: 8 or 9 weeks
- Weight at study initiation: 189 to 223 g

- Fasting period before study: 1 d
- Housing: solid-bottomed clear polycarbonate cages with stainless steel mesh lid
- Diet: M20, SDS ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 300 mg or 2 g in 10 ml olive oil
- Amount of vehicle (if gavage): 10 ml / kg bw
Doses:
300 mg and 2 g /kg bw
No. of animals per sex per dose:
3 animals per dose, no consideration on sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at day 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
no statistics were performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
other: LD50 cut-off
Effect level:
ca. 500 mg/kg bw
Based on:
other: OECD guideline
Mortality:
At a dose of 2 g /kg bw, all animals died three hours after exposure.
At a dose of 300 mg/kg bw, all animals survived.
Clinical signs:
In the hours after exposure, the animals showed a decrease or absence in spontaneous activity, in muscle tone, in righting reflex and in Preyer's reflex, mydriasis, lacrymation, bradypnea and partial ptosis.
In the group treated with 300 mg / kg bw, not all animals showed all symptoms, some showed additionally piloerection and chromodacryorrhea.
Body weight:
The animals in the Group treated with 300 mg/kg bw gained bodyweight normally throughout the study.
Gross pathology:
The animals treated with a dose of 2 g/kg bw showed a thinning of the forestomach and corpus, associated with a white coloration and black spots.
No changes were observed for the animals treated with 300 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test item 1,2,3-Benzotriazole is higher than 300 mg/kg and lower than 2000 mg /kg body weight by oral route in the rat.
In accordance with the OECD guideline No. 423, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.