Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 may to 16 July 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
Range finding:
5000 mg/kg, 2000 mg/kg, 1000 mg/kg, 500 mg/kg, 200 mg/kg,
Main study
707 mg/kg, 1000 mg/kg, 1400 mg/kg,
No. of animals per sex per dose:
Main study 5 per sex
Sex:
male/female
Dose descriptor:
LD50
Effect level:
870 mg/kg bw
Based on:
test mat.
95% CL:
> 812 - < 933

Dose level mg/kg

Sex

Number of Animals treated

Deaths During Day of Dosing (hour)

Deaths During Day of Dosing (days)

Deaths

%

1/2

1

2

4

1

2

3

4

5

6

7

8-14

707

Male

female

5

5

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

1000

Male

female

5

5

0

0

0

0

0

0

0

0

4

5

0

-

0

-

0

-

0

-

0

-

0

-

0

-

0

-

0

-

1414

Male

female

5

5

0

0

2

2

0

1

0

1

3

1

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2-Chloro-4,6-dimethoxy-1,3,5-Triazin has a LD50 of 870 mg/kg when administred orally. Hence it has to be classified as harmful.
Executive summary:

A study with Spague-Dawley rats was performed according to OECD 401. After a range finding study the doses 707 mg/kg 1000 mg/kg and 1414 mg/kg were given by gavage. Deaths and clinical signs were observed.

The acute oral median lethal dose LD50 and 95% confidence limit of the test material were calculated by the method of Thompson W R to be: 870 (812 - 913) mg/kg bodyweight.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
870 mg/kg bw
Quality of whole database:
sufficient

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-01-16 to 1995-02-15
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: no guideline followed but sufficientlydocumented
Qualifier:
no guideline followed
Principles of method if other than guideline:
Substance was applied to clipped skin of a rabbit
Mortality and clinical abnormalities were observed
GLP compliance:
no
Test type:
standard acute method
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
water
Duration of exposure:
24h
Doses:
1000mg/kg bw
No. of animals per sex per dose:
3 animals per dose
Sex:
not specified
Dose descriptor:
LD0
Effect level:
> 1 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
other: Substance is considered corrosive to rabbit skin.

Study abnormalities

Animals affected

No observed / No Dosed

Day(s) of Occurrence

Mortality

0/3

-

Well-defined erythema

3/3

1-12

Very slight erythema

2/3

13-14

Blanching – mild

2/3

2-8

Blanching - moderate

2/3

5

Blanching – focal/pinpoint

2/3

3,4,8,9

Eschar – mild

2/3

4-14

Eschar - focal/pinpoint

2/3

2,3,10-14

Desquamation

3/3

6-14

Severe edema

3/3

1-4

Moderate edema

3/3

3-7

Slight edema

3/3

5-9

Very slight edema

3/3

9-14

Fecal stain

1/3

1,2

Few feces

3/3

3-5

Low food consumption

2/3

3,4

Dehydration

1/3

4-6

Ancillary irritation on the trunk outside the test site

1/3

1-7

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
2-Chloro-4,6-Dimethoxy-1,3,5-Triazine does not result in mortality of Rabbits with 1000mg/kg bw. no classification for dermal toxicity is necessarry
Executive summary:

Based on the result of this study, the acute dermal Median Lethal Dose (MLD) of 08699 (equivalent to 2-Chloro-4,6-Dimethoxy-1,3,5-Triazine) was estimated to be greater than 1000 mg/kg in the rabbit. The calculated primary irritation indes was 6.33 which classifies this dose level as a severe irritant to the dermal tissue of the rabbit.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
sufficient

Additional information

Justification for selection of acute toxicity – oral endpoint
guideline study with sufficient documentation

Justification for selection of acute toxicity – dermal endpoint
no guideline followed but sufficiently documented and only study available

Justification for classification or non-classification

Classification acut oral toxicity 4 because of LD50 oral is found to be 870 mg/kg bw in a guideline study.

No classification for acute dermal tox because in a non guideline study there were no deaths oserved up to 1000mg/kg bw.