Registration Dossier
Registration Dossier
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EC number: 255-255-2 | CAS number: 41198-08-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 October 2005 to 10 November 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 59 NohSan No. 4200 (1985)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- EC Number:
- 255-255-2
- EC Name:
- O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate
- Cas Number:
- 41198-08-7
- Molecular formula:
- C11H15BrClO3PS
- IUPAC Name:
- 4-bromo-2-chlorophenyl ethyl (propylsulfanyl)phosphonate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- Single application
- Observation period:
- 72 hrs
- Number of animals:
- 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not specified
Any other information on results incl. tables
Individual skin irritation scores are presented below, All animals appeared active and healthy. Apart from the skin irritation noted below, there were no other signs of gross toxicity, adverse pharmacological effects or abnormal behaviour.
One hour after patch removal, well defined erythema and slight oedema were noted for all three treated sites. The overall incidence and severity of irritation decreased with time. Apart from desquamation noted at all dose sites on Day 7, all animals were free from dermal irritation by study terminatin (Day 7).
The Primary Dermal Irritation Index for Profenofos Technical is 3.1.
Table 7.3.1-1: Individual and mean skin irritation scores according to the Draize scheme
|
Erythema/Oedema |
|||
Animal no |
15535/M |
15536/F |
15537/M |
Total |
|
4 HOUR EXPOSURE |
|||
1 hr |
2/2 |
2/2 |
2/2 |
6/6 |
24 hr |
2/2 |
2/2 |
2/1 |
6/5 |
48 hr |
1/1 |
2/1 |
2/1 |
5/3 |
72 hr |
1/0 |
1/0 |
2/1 |
4/1 |
7 days |
0/0* |
0/0* |
0/0* |
0/0* |
Mean |
2.0/2.0 |
2.0/1.7 |
1.7/1.0 |
1.3/0.7 |
* Desquamation present at dose site
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the test material is classified as moderately irritating to the skin.
- Executive summary:
In a primary dermal irritation study,3 young adult New Zealand rabbits, 2 males and 1 females, were exposed via the dermal route to 0.5 mL of Profenofos Technical/animal. The test material was administered semi occluded as supplied for 4 hours to a clipped area of intact skin measuring ~1 inch2. Animals were then observed for 7 days. Irritation was scored using the Draize scheme.
Under the conditions of this study, the test material is classified as moderately irritating to the skin.
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