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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report with restrictions (no data on test substance purity and body weight development, no GLP)

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978
Reference Type:
other: Correspondence
Title:
Unnamed
Year:
1989
Report date:
1989
Reference Type:
publication
Title:
Unnamed
Year:
2001
Reference Type:
publication
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(no data on test substance purity and body weight development)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
EC Number:
247-384-8
EC Name:
2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol
Cas Number:
25973-55-1
Molecular formula:
C22H29N3O
IUPAC Name:
2-(2H-benzotriazol-2-yl)-4,6-bis(1,1-dimethylpropyl)phenol

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 160-180 g
- Fasting period before study: overnight
- Housing: in groups of 5 in Macrolon cages (type 3)
- Diet (ad libitum): rat food - NAFAG, Gossau SG
- Water (ad libitum)
- Acclimation period: a minimum of 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
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 % of Formulation

DOSAGE PREPARATION: Before treatement the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
Doses:
4640, 6000, 7750 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.
- Necropsy of survivors performed: yes (submitted at random to a necropsy at the end of the observation period)

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: No mortality occured.
Mortality:
No mortality occured.
Clinical signs:
other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoe, curved position and ruffled fur. The animals recovered within 8 to 9 days.
Gross pathology:
No substance related gross organ changes were seen.

Applicant's summary and conclusion