Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

dec 1990 (test) until Jan 1991 (report finished)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline conform study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

EC Number:

410-560-1

EC Name:

Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Cas Number:

153519-44-9

Molecular formula:

C28 H28 N3 O4 + C12 H25 / C13 H27 (represents two main components)

IUPAC Name:

Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxy phenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Test animals

Species:

rat

Strain:

other: Tif: RAI f (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production 4332 Stein / Switzerland
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 174-213g
- Fasting period before study:
- Housing: The animals were housed in Macrolon cages type 4, with standardized soft wood bedding (Societe Parisienne des Sciures, Pantin, France).
- Diet (e.g. ad libitum): ad libitum, (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%):55+/-10
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light):12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: oil arachidis

Details on oral exposure:

VEHICLE
0l. arachidis Ph.H.VI (Siegfried AG, Zofingen, Switzerland)

MAXIMUM DOSE VOLUME APPLIED: 10ml/kg bw

Doses:

2000 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 and weighing: observation daily, weighing immediately before administration and on days 7 and 14
- Necropsy of survivors performed: yes

Statistics:

From the body weights, the group means and their standard
deviations were calculated.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occurred in this study.

Clinical signs:

other: Piloerection, hunched posture, exophthalmos, and dyspnea were seen, being common symptoms in acute tests.

Gross pathology:

At autopsy, no deviations from normal morphology were found.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 was determined: > 2000 mg/kg bw