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EC number: 276-743-1 | CAS number: 72624-02-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-10-25 to 1991-11-2
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study with 24 hour exposure and termination at 72 hours without evidence of reversibility
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- skin was not abraded
- Principles of method if other than guideline:
- Group 1:
One intact site per rabbit treated with pure (100%) test material.
Group 2:
4 intact sites per rabbit treated with four single applications of the test material at concentrations of 50, 25, 12.5 and 6.25% in light, white mineral oil. - GLP compliance:
- yes
Test material
- Reference substance name:
- Phenol, heptyl derivs.
- EC Number:
- 276-743-1
- EC Name:
- Phenol, heptyl derivs.
- Cas Number:
- 72624-02-3
- Molecular formula:
- C13H20O
- IUPAC Name:
- 4-(2-methylhexyl)phenol; 4-heptylphenol
- Details on test material:
- - Analytical purity: 100%
- Physical state: brown liquid
- Stability under test conditions: Considered stable under normal storage conditions
- Storage condition of test material: Sealed container at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Products Inc., Denve, Pennsylvania, USA
- Age at study initiation: Young adult
- Weight at study initiation: 2715 - 3176 g
- Housing: Individual suspended wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66 - 70°F
- Humidity (%): 43 - 72%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
IN-LIFE DATES: From: 1991-10-25 To: 1991-11-02
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: light white mineral oil
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site
- Concentration (if solution): 100%
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 50, 25, 12.5 and 6.5% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 12 rabbits (3 male, 9 female)
2 x group of 6 rabbits - Details on study design:
- TEST SITE
Group 1
- Area of exposure: back, 1" x 1" patch, one site only
- % coverage: not specified
Group 2
- Area of exposure: back, 1" x 1" patch, 4 sites per rabbit
- % coverage: not specified
- Type of wrap if used: 2 ply gauze patch overwrapped with a gauze binder and secured with Dermiform tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, disposal paper towels moistened with tepid tap water
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hour
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 100% test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 2.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 100% test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 50% test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 50% test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 2.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 25% test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 25% test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 12.5% test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 12.5% test material
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: 6.25% test material
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 and 72 hours
- Score:
- 0.58
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- other: 6.25% test material
- Irritant / corrosive response data:
- Dermal observations (See Table 1)
In Group 1, neat (100%) test material induced severe erythema and slight to moderate oedema. Eschar was present on all sites. Exfoliation and necrosis were noted on two sites each. There were no other dermal findings.
In Group 2, the 6.25% w/v concentration induced very slight to slight erythema and oedema on six and three sites respectively. Desquamation was noted on one site. There were no other dermal findings
In Group 2, the 12.5% w/v concentration induced slight to moderate erythema and very slight to slight oedema. Desquamation was present on one site. There were no other dermal findings.
In Group 2, the 25% w/v concentration induced slight to severe erythema and oedema. Eschar was noted on two sites. There were no other dermal findings.
In Group 2, the 50% w/v concentration induced severe erythema and moderate to severe oedema. Eschar was present on all sites. Blanching was noted on one site. - Other effects:
- Mortality:
None of the rabbits died.
Body weights:
There were no treatment related effects on bodyweight
Any other information on results incl. tables
Table 1: Observations
Rabbit Number |
Erythema |
Oedema |
||
24 h |
72 h |
24 h |
72 h |
|
100% |
||||
1 |
4e |
4e |
3 |
3 |
2 |
4e |
4e |
3 |
2 |
3 |
4e |
4ex |
2 |
2 |
4 |
4e |
4en |
3 |
2 |
5 |
4e |
4en |
3 |
2 |
6 |
4e |
4ex |
2 |
3 |
Mean Total |
4.0 |
2.5 |
||
50% |
||||
1 |
4e |
4e |
3 |
3 |
2 |
4e |
4e |
4 |
3 |
3 |
4e |
4e |
4 |
3 |
4 |
4e |
4e |
4 |
3 |
5 |
4be |
4be |
4 |
4 |
6 |
4e |
4e |
3 |
3 |
Mean Total |
4.0 |
3.4 |
||
25% |
||||
1 |
4e |
4e |
4 |
4 |
2 |
2 |
2 |
2 |
2 |
3 |
3 |
3 |
3 |
3 |
4 |
2 |
2 |
2 |
2 |
5 |
3 |
4e |
3 |
3 |
6 |
3 |
3 |
2 |
2 |
Mean Total |
2.9 |
2.67 |
||
12.5% |
||||
1 |
3 |
2 |
2 |
2 |
2 |
2 |
1d |
1 |
0 |
3 |
2 |
2 |
2 |
2 |
4 |
2 |
2 |
1 |
1 |
5 |
2 |
2 |
2 |
2 |
6 |
2 |
2 |
1 |
2 |
Mean Total |
2.0 |
1.5 |
||
6.25% |
||||
1 |
2 |
2 |
2 |
1 |
2 |
2 |
2 |
1 |
1 |
3 |
2 |
2 |
1 |
1 |
4 |
1 |
1 |
0 |
0 |
5 |
1 |
1d |
0 |
0 |
6 |
1 |
1 |
0 |
0 |
Mean Total |
1.5 |
0.58 |
||
e = eschar
n = necrosis
x = exfoliation
d = desquamation
b = blanching
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive)
- Remarks:
- Migrated information Pure test material Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the pure test material induced necrosis in 2 out of 6 animals by the 72 hour observation period and at the 50% w/v concentration, blanching was seen in one out of 6 animals. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is required for skin corrosivity/irritation.
Erythema and oedema scores for the 12.5% w/v concentration would preclude the classification as a skin irritant at this dose level. However in the absence of observations beyond the 72 hour time point the potential for reversibilty of these effects is unknown. Therefore classification as Cat 2: Irritant is applicable at this concentration level. - Executive summary:
Test Guidance
Skin irritation study performed by a similar method to US OPP 81-5.Method and Material
Group 1:
Six New Zealand White rabbits were shaved and a 0.5 mL portion of the test material was applied to an intact skin site. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 4 hours and washed .
Group 2:
Six New Zealand White rabbits were shaved and 4 intact sites per rabbit treated with four single applications of 0.5 mL each of the test material at concentrations of 50, 25, 12.5 and 6.25% in light, white mineral oil. A gauze patch was placed over each application site and an impervious material was wrapped around the trunk of the animal to hold the patches. The wrapping was removed after 4 hours and washed .
Treated areas were examined for erythema and oedema using the Draize method of scoring at 24 and 72 hours.
Results
In Group 1, neat (100%) test material induced severe erythema and slight to moderate oedema. Eschar was present on all sites. Exfoliation and necrosis were noted on two sites each. There were no other dermal findings.
In Group 2, the 6.25% w/v concentration induced very slight to slight erythema and oedema on six and three sites respectively. Desquamation was noted on one site. There were no other dermal findings In Group 2, the 12.5% w/v concentration induced slight to moderate erythema and very slight to slight oedema. Desquamation was present on one site. There were no other dermal findings.
In Group 2, the 25% w/v concentration induced slight to severe erythema and oedema. Eschar was noted on two sites. There were no other dermal findings.
In Group 2, the 50% w/v concentration induced severe erythema and moderate to severe oedema. Eschar was present on all sites. Blanching was noted on one site.
The only evidence of reversibility over the limited timeframe of the study was for oedema responses at the 6.25% test concentration.
Conclusion
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is required for skin corrosion/irritation.
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