Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study design states it complies and it follows lates OECD guideline 404 (1981). Contains sufficient detail to suggest GLP-like characteristics even though no statement of certification is reported (reasonably thorough description of authors, dates, design, results, and interpretation).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Appraisal of the safety of Chemicals in Foods, Drug and Cosmetics by the staff of the division of pharmacology, FDA.
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
version of May 1981
Deviations:
not specified
Qualifier:
according to
Guideline:
other: The Code of Draize (1957)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Atrazine technical
Appaerance: white powder
Supplier: OXON Italia S.p.A.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Eight adult white New Zealand ( 4 fames and 4 males) per test substance were used for the procedure. They were 6 to 8 months old and weighted about 2.5 to 3.5 Kg. they were housed in individual cages at a laboratory standard diet for rabbits (Altromin, lage, germany) and were watered ad libitum.
The room temperature was constantly ca 18°C (max. limit), the relative atmospheric humidity 55 to 65%, the daily illumination 12 hours.

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5g of atrazina (technical) were deposited on a gauze square of 2.5cm, about 5 ml of aqua font. were added and applied to the animal.
Duration of treatment / exposure:
7 days
Observation period:
One reading was performad after 24 hours after the application of the test material on the animal, the second reading was performed 72 hors later.
Number of animals:
Eight animals per each group were used

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 24, 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 hors
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal: #7
Time point:
other: 24, 72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal: #8
Time point:
other: 24, 72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal: #7
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
animal: #8
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.19
Irritant / corrosive response data:
the substance Atrazine technical caused to the intact no skin irritation to any animal within first 24 hors.
only slight erythema was observed to scarified skin after 24 hours of contact.
48 hours later no animal showed differences to normal skin.

Any other information on results incl. tables

Score of skin irritation:

Animal

No.

Response

24 hours score

                             

72 hours score

Average

score

7 days score

Intact

abraded

intact

abraded

intact

abraded

1

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

2

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

3

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

4

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

5

Erythema

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

6

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

7

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

8

Erythema

0

1

0

0

0.25

0

0

Oedema

0

0

0

0

0

0

Primary Irritation Index

0.19

 

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: ETAD SUB-COMMITEE FOR TOXICOLOGY
Conclusions:
According to the scoring of ETAD SUB-COMMITEE FOR TOXICOLOGY the index of primary irritation was 0.19. The substance is considered to be "slightly irritant".