Registration Dossier
Registration Dossier
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EC number: 605-717-8 | CAS number: 174333-80-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(hydroxyimino)methyl]-4-(2-methyloctyl)phenol; 2-[(hydroxyimino)methyl]-4-(3-methyloctyl)phenol; 2-[(hydroxyimino)methyl]-4-(4-methyloctyl)phenol; 2-[(hydroxyimino)methyl]-4-(nonan-2-yl)phenol
- EC Number:
- 605-717-8
- Cas Number:
- 174333-80-3
- Molecular formula:
- C16H25NO2
- IUPAC Name:
- 2-[(hydroxyimino)methyl]-4-(2-methyloctyl)phenol; 2-[(hydroxyimino)methyl]-4-(3-methyloctyl)phenol; 2-[(hydroxyimino)methyl]-4-(4-methyloctyl)phenol; 2-[(hydroxyimino)methyl]-4-(nonan-2-yl)phenol
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): SAT 960 405
- Physical state: amber-colourd, viscous liquid
- Lot/batch No.: 070596
- Expiration date of the lot/batch: 09/1997
- Storage condition of test material: room temperture, dark
- Impurities: nonyl phenol < 7%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mollegaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved
- Age at study initiation: no data
- Weight at study initiation: 2.0 - 2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit diet "Altromin 2123" from Altromin; ad libitum
- Water (e.g. ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Air changes (per hr): 10 times / hour
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4h
- Observation period:
- 21 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: two 16-layer gauze patches (2.5 x 2.5 cm)
- Type of wrap if used: Micropore tape, 5 cm width
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm water
- Time after start of exposure: 4h
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after termination of exposure as well as 7, 14 and 21 days
SCORING SYSTEM:
- Method of calculation: The respective scores for erythema and oedema formation for the 3 readings 24, 48 and 72 hours of each rabbit were summed up separately and divided by 6. The results are the mean scores for erythema and oedema formation of the individual rabbit.
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: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Conclusions:
- Based on the results of a study according to OECD Test Guideline 404 under GLP, the test substance is considered as skin irritating (applying the evaluation system of the EU regulation 1272/2008).
- Executive summary:
The skin irritation potential of the test substance was evaluated in a study according to OECD Test Guideline 404 under GLP.
The amount of 0.5 ml of the substance was applied unchanged under semi-occlusive conditions for 4 hours to the clipped skin of three Mol:Russian rabbits, which were observed for 21 days post application. Over the first three days, clear erythema and oedema were observed in all rabbits, which reversed fully within 21 days.
Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered irritating to the skin.
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