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Registration Dossier
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EC number: 947-842-3 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- assessment report
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Justification for read-across is provided in chapter 13 as separate statement
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 weeks (males, females)
- Weight at study initiation: 2.2 kg (male); 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark / light - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / animal
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hour
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- % coverage: 100
- Type of wrap if used: surgical gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Irritation scoring according to Council Regulation (EC) No 440/2008 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Other effects:
- Scaling noted
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritation property of the registration substance is assessed based on the read-across to Sodium N-cocoyl glycinate.
Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the Guideline OECD 404. It is not skin irritating.
Likewise the registration substance is not skin irritating. - Executive summary:
The skin irritation property of the registration substance is assessed based on the read-across to Sodium N-cocoyl glycinate.
Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the OECD 404. 0.5 ml of the test material was semi occusively applied to the clipped skin area of rabbits for 4 hours. Three animals were treated. Mild erythema and edema was found in all treated animals and these effects disappeard within 14 days. Sodium N-cocoyl glycinate is not skin irritating.
Likewise, the registration substance is not skin irritant.
Table: Skin irritation scores |
||||||
Observation Time |
Erythema |
Oedema |
||||
Animal 1 |
Animal 2 |
Animal 3 |
Animal 1 |
Animal 2 |
Animal 3 |
|
1h |
2 |
2 |
2 |
1 |
2 |
1 |
24h |
2 |
2 |
2 |
1 |
2 |
1 |
48h |
1 |
2 |
2 |
1 |
1 |
1 |
72h |
1 |
1 |
2 |
1 |
1 |
1 |
7 day |
0 |
1 |
0 |
0 |
0 |
0 |
10 day |
0 |
0 |
0 |
0 |
0 |
0 |
14 day |
0 |
0 |
0 |
0 |
0 |
0 |
Mean of 24/48/72h |
1.33 |
1.67 |
2 |
1 |
1.33 |
1 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Sodium cocoyl glycinate (SCG) [INCI]
- IUPAC Name:
- Sodium cocoyl glycinate (SCG) [INCI]
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands BV
- Age at study initiation: 14 weeks (males, females)
- Weight at study initiation: 2.2 kg (male); 2.5 kg (females)
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: yes
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 10 - 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hour cycle dark / light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL / animal
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hour
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 10 cm x 10 cm
- % coverage: 100
- Type of wrap if used: surgical gauze patch
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours
SCORING SYSTEM: Irritation scoring according to Council Regulation (EC) No 440/2008
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Other effects:
- Scaling noted
Any other information on results incl. tables
Table: Skin irritation scores |
||||||
Observation Time |
Erythema |
Oedema |
||||
Animal 1 |
Animal 2 |
Animal 3 |
Animal 1 |
Animal 2 |
Animal 3 |
|
1h |
2 |
2 |
2 |
1 |
2 |
1 |
24h |
2 |
2 |
2 |
1 |
2 |
1 |
48h |
1 |
2 |
2 |
1 |
1 |
1 |
72h |
1 |
1 |
2 |
1 |
1 |
1 |
7 day |
0 |
1 |
0 |
0 |
0 |
0 |
10 day |
0 |
0 |
0 |
0 |
0 |
0 |
14 day |
0 |
0 |
0 |
0 |
0 |
0 |
Mean of 24/48/72h |
1.33 |
1.67 |
2 |
1 |
1.33 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the Guideline OECD 404. It is not skin irritating.
- Executive summary:
Sodium N-cocoyl glycinate was investigated for its skin irritation property according to the OECD 404. 0.5 ml of the test material was semi occusively applied to the clipped skin area of rabbits for 4 hours. Three animals were treated. Mild erythema and edema was found in all treated animals and these effects disappeard within 14 days. Sodium N-cocoyl glycinate is not skin irritating.
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