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Registration Dossier
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EC number: 201-193-6 | CAS number: 79-29-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it closely follows OECD guideline 404.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restriction because it closely follows OECD guideline 404.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- group score erythema
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- group score edema
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- SBP 60/95 LNH caused mild irritation lasting through 72 hrs.
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24,48, and 72 hours) was 0.8. The average oedema score (24,48, and 72 hours) was 0.0.
- Executive summary:
This data is being read across from the source study that tested Hexane Solvent with <5% n-hexane based on analogue read across.
This study examined the skin irritancy of the test substance SBP 60/95 LNH. Groups of six rabbits had 0.5 mL of test substance applied to their dorsal skin. The test area was covered semi-occlusively, and exposure lasted 4 hrs. The test area was then washed.
Animals were scored at 30 min., 24 hrs, 48 hrs, 72 hrs, and 7 days after removal of the test substance. The average erythema score (24,48, and 72 hours) was 0.8. The average oedema score (24,48, and 72 hours) was 0.0.
Skin Irritation Results – SBP 60/95 LNH
Animal |
Observation |
|||||
Hours |
Day |
|||||
4 |
24 |
48 |
72 |
7 |
||
806-M |
Erythema |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
821-M |
Erythema |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
803-M |
Erythema |
1 |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
812-F |
Erythema |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
813-F |
Erythema |
1 |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
820-F |
Erythema |
1 |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- <5% n-hexane
- IUPAC Name:
- <5% n-hexane
- Reference substance name:
- SBP 60/95 LNH
- IUPAC Name:
- SBP 60/95 LNH
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre Breeding Unit
- Age at study initiation: 4-9 months
- Weight at study initiation: 2926-4988 g
- Housing: singly in 67 x 43 x 45 cm stainless steel, wire-mesh cages, identified by metal ear tags
- Diet (e.g. ad libitum): Standard Rabbit Diet, S.Q.C., ad libitum
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period: at least two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 degree C
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 7 days
- Number of animals:
- 3 male/3 female
- Details on study design:
- TEST SITE
- Area of exposure: Hair was short between the shoulders and hindquarters. A 2x2 cm lint patch with 0.5 ml of test substance was applied.
- Type of wrap if used: The patch was covered with a single layer of gauze held in place with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were washed with water.
- Time after start of exposure: 4 hrs
SCORING SYSTEM: Animals were scored for erythema and edema on a scale of 0 (no effects) to 4 (severe effects).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- group score erythema
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- group score edema
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- SBP 60/95 LNH caused mild irritation lasting through 72 hrs.
Any other information on results incl. tables
Skin Irritation Results – SBP 60/95 LNH
Animal |
Observation |
|||||
Hours |
Day |
|||||
4 |
24 |
48 |
72 |
7 |
||
806-M |
Erythema |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
821-M |
Erythema |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
803-M |
Erythema |
1 |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
812-F |
Erythema |
1 |
1 |
1 |
1 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
813-F |
Erythema |
1 |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
820-F |
Erythema |
1 |
1 |
1 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The average erythema score (24,48, and 72 hours) was 0.8. The average oedema score (24,48, and 72 hours) was 0.0.
- Executive summary:
This study examined the skin irritancy of the test substance SBP 60/95 LNH. Groups of six rabbits had 0.5 mL of test substance applied to their dorsal skin. The test area was covered semi-occlusively, and exposure lasted 4 hrs. The test area was then washed.
Animals were scored at 30 min., 24 hrs, 48 hrs, 72 hrs, and 7 days after removal of the test substance. The average erythema score (24,48, and 72 hours) was 0.8. The average oedema score (24,48, and 72 hours) was 0.0.
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