Registration Dossier
Registration Dossier
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EC number: 217-617-8 | CAS number: 1912-24-9
Skin irritation / corrosion
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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- 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
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- version of May 1981
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: The Code of Draize (1957)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Atrazine
- EC Number:
- 217-617-8
- EC Name:
- Atrazine
- Cas Number:
- 1912-24-9
- Molecular formula:
- C8H14ClN5
- IUPAC Name:
- 6-chloro-N2-ethyl-N4-(propan-2-yl)-1,3,5-triazine-2,4-diamine
- Details on test material:
- Atrazine technical
Appaerance: white powder
Supplier: OXON Italia S.p.A.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system 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".
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