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Registration Dossier
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EC number: 217-682-2 | CAS number: 1929-82-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 August 2006 to 05 August 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to valid guidelines, and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- (see "Principles of method if other than guideline")
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (see "Principles of method if other than guideline")
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (see "Principles of method if other than guideline")
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12-Nouan-8147 (2000)
- Deviations:
- yes
- Remarks:
- (see "Principles of method if other than guideline")
- Principles of method if other than guideline:
- Due to a technical oversight, the pH of the test material was determined after the in-life phase was completed. This deviation did not adversely impact the outcome of this study.
Furthermore, the protocol requires individual body weights of animals to be recorded prior to application and at study termination; due to a technician oversight, the animals’ body weight at termination were not recorded. This deviation did not adversely impact the outcome of this study. - GLP compliance:
- yes
Test material
- Reference substance name:
- Nitrapyrin
- EC Number:
- 217-682-2
- EC Name:
- Nitrapyrin
- Cas Number:
- 1929-82-4
- Molecular formula:
- C6H3Cl4N
- IUPAC Name:
- 2-chloro-6-(trichloromethyl)pyridine
- Test material form:
- solid: crystalline
- Details on test material:
- - Appearance: white crystalline solid
- Stability under test conditions: expected to be stable for the duration of testing
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2.5 - 2.8 kg
- Housing: singly housed in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least three times per week.
- Water: Filtered tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 61 - 70 %
- Air changes (per hr): 27 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of darkness / 12 hours of light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- test material was applied as a dry paste (75 % w/w mixture in distilled water)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- The test material was moistened with distilled water to achieve a dry paste by preparing a 75 % w/w mixture in distilled water. Five-tenths of a gram of the test material (0.67 grams of test mixture) was applied to the skin. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: The hair was clipped one day prior to dosing. The test material was placed on a 1 x 1 inch, 4-ply gauze pad and applied to one 6 cm² intact dose site on each animal.
- Type of wrap if used: The pad and entire trunk of each animal were then wrapped with semi-occlusive 3-inch Micropore tape to avoid dislocation of the pad. Elizabethan collars were placed on each rabbit and they were returned to their designated cages.
REMOVAL OF TEST MATERIAL
- After 4 hours of exposure to the test material, the pads and collars were removed and the test sites were gently cleansed with a 3 % soap solution and tap water and a clean towel to remove any residual test material.
SCORING SYSTEM
- Individual dose sites were scored according to the Draize scoring system (see Table 1) at approximately 30-60 minutes, 24, 48, and 72 hours after patch removal.
OTHER OBSERVATIONS
- Individual body weights of the animals were recorded prior to test substance application.
- The animals were observed for signs of gross toxicity and behavioural changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, and coma.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal # 2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- Animal # 3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal # 1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal # 2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- Animal # 3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- One hour after patch removal, well-defined erythema and very slight oedema were noted for all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 72 hours.
- Other effects:
- All animals appeared active and healthy during the study. Apart from the skin irritation responses, there were no other signs of gross toxicity, adverse clinical signs, or abnormal behaviour.
Any other information on results incl. tables
Table 2: Individual Skin Irritation Scores (erythema/oedema)
Animal no. |
Sex |
Time after patch removal |
|||
30 - 60 min |
24 hours |
48 hours |
72 hours |
||
3501 |
M |
2/1 |
1/0 |
1/0 |
0/0 |
3502 |
M |
2/1 |
1/0 |
1/0 |
0/0 |
3503 |
M |
2/1 |
2/1 |
2/1 |
0/0 |
Total |
6/3 |
4/1 |
4/1 |
0/0 |
|
Mean |
2.0/1.0 |
1.3/0.3 |
1.3/0.3 |
0.0/0.0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- Under the conditions of the study, the test material was found to be not irritating to the skin of New Zealand White rabbits.
- Executive summary:
The skin irritation potential of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines EPA OPPTS 870.2500, OECD 404, EU Method B.4 and JMAFF 12 -Nouan-8147.
During the study 0.5 g of test material was moistened with distilled water and then applied to the clipped skin of three healthy New Zealand White rabbits for 4 hours in a semi-occlusive fashion. Following exposure, dermal irritation was evaluated by the method of Draize. One hour after patch removal, well-defined erythema and very slight oedema were noted for all three treated sites. The overall incidence and severity of irritation decreased with time. All animals were free from dermal irritation within 72 hours.
All animals appeared active and healthy during the study. There were no signs of gross toxicity, adverse clinical signs, or abnormal behaviour.
Under the conditions of the study, the test material was found to be not irritating to the skin of New Zealand White rabbits.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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