Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline methods with acceptable restrictions - analytical purity of test article was not given in the report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(dosing volume > 10 mL/kg bw, 10/14 hour light/dark cycle, acclimation period = 4 days)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid

Specific details on test material used for the study:
- Name as cited in publication: 2 - [2' hydroxy - 3', 5' - bis- (alpha, aplha dimethylbenzyl) phenyl]-benzotriazole
- Batch number: A 16-234/5
- Analytical purity: no data
- Physical state: solid

Test animals

Species:
rat
Strain:
other: Tif RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba Geigy Ltd.
- Age: 7 to 8 wks
- Mean weight range at study initiation: 173 - 187 g (♂) and 175 - 184 g (♀)
- Fasting period before study: overnight
- Housing: 5/cage (macrolon cages type V)
- Diet: ad libitum; NAFAG Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 14/10

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
(400)
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10, 20, 30 %
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: Test substance is insoluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 - 25.8 mL/kg bw

DOSAGE PREPARATION
A test substance suspension was prepared. Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
1,000, 2,150, 4,640 and 7,750 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Physical condition and rate of deaths were monitored throughout the whole observation period.
- Frequency of weighing: body weights were recorded immediately prior to dosing (control weights) and 7 and 14 days post treatment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 7 750 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Highest dose tested. Mortality did not occur in any dose group.
Mortality:
No mortality was detected in any group
Clinical signs:
- 1,000 mg/kg bw: sedation, dyspnoea, exophthalmos, ruffled fur and curved body position (symptoms starting as early as 1 hour post dosing, fully reversible within 8 days)
- 2,150 and 4,640mg/kg bw: sedation, dyspnoea, exophthalmos, ruffled fur and curved body position (symptoms starting as early as 1 hour post dosing, fully reversible within 10 days)
- 7,750 mg/kg bw: sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position (symptoms starting as early as 1 hour post dosing, fully reversible within 8 days)

Body weight:
see table 1
Gross pathology:
No substance related gross organ changes were seen at the necropsy of sacrificed animals

Any other information on results incl. tables

Table 1: Table of Body weights (acute oral toxicity)

 

 

Dose (mg/kg bw)

 

 

1,000

2,150

4,640

7,750

Day 1

187 ± 7.1

173 ± 2.3

175 ± 3.7

181 ± 1.6

184 ± 4.1

179 ± 1.3

175 ± 2.8

163 ± 4.5

Day 7

251 ± 9.6

233 ± 9.8

250 ± 8.3

237 ± 1.8

219 ± 6.1

216 ± 5.2

210 ± 7.5

194 ± 6.6

Day 14

289 ± 17.0

285 ± 11.6

298 ± 17.2

288 ± 8.7

248 ± 7.0

239 ± 4.0

233 ± 9.7

217 ± 7.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met