Registration Dossier
Registration Dossier
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EC number: 296-229-0 | CAS number: 92368-90-6
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1985-05-22 to 1985-05-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- yes
- Principles of method if other than guideline:
- The deviations were:
- a shorter observation time for only 7 days
- identification and stability of the test material and stability of its preparations were not determined - GLP compliance:
- yes
Test material
- Reference substance name:
- 2-benzylheptanol
- EC Number:
- 296-229-0
- EC Name:
- 2-benzylheptanol
- Cas Number:
- 92368-90-6
- Molecular formula:
- C14H22O
- IUPAC Name:
- 2-benzylheptan-1-ol
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: 12-16 weeks
- Weight at study initiation: 2.45-2.66 kg
- Housing: individually, in suspended metal cages
- Diet: ad libitum, Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire
- Water: ad libitum, tap water
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 ± 1.5
- Humidity (%): 50-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: petroleum jelly B.P.
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL
- Concentration: undiluted (100), 25, 5 and 1 % - Duration of treatment / exposure:
- 4 h
- Observation period:
- 7 days.
Observations done at 1, 24, 48 and 72 h after removal and at day 7. - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: surgical gauze two layers thick secured with a cross of Sleek adhesive strapping, in addition elasticated corset (Tubigrip)
REMOVAL OF TEST SUBSTANCE
- Washing: gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: immediately after 4 h treatment
SCORING SYSTEM: Draize J.H. (1959)1959), Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" Details on scouring system see "Any other information"
Interpretation of Results:
For each test material concentration the scores for erythema and oedema at the 24 and 72 hour readings were totaled for the three test rabbits (12 values). This total was divided by 6 to give the Primary Cutaneous Irritation Index of each of the four concentrations. This index was used to classify the skin irritation properties of each test material concentration according to the following scheme (after Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics")
Details on Primary Cutaneous Irritation Index interpretation see "Any other information"
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 25 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 5 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 1 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 25 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 5 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- 100 % test substance
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Mean scores
| Concentration [%] | Mean Erythema score (24/48/72 h) | Mean Edema score (24/48/72 h) |
| 100 | 1.89 | 0.67 |
| 25 | 0.22 | 0.00 |
| 5 | 0.00 | 0.00 |
| 1 | 0.00 | 0.00 |
Individual scores
| Animal | Concentration [%] | Timepoint [h] | Erythema score (of max. 4) | Edema score (of max. 4) |
| 1 | 100 | 1 | 1.00 | 0 |
| 24 | 2.00 | 1 | ||
| 48 | 2.00 | 1 | ||
| 72 | 2.00 | 0 | ||
| 7 days | 1.00 | 0 | ||
| mean (24/48/72h) | 2.00 | 0.67 | ||
| 25 | 1 | 1.00 | 0 | |
| 24 | 1.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.33 | 0.00 | ||
| 5 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 1 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 2 | 100 | 1 | 1.00 | 1 |
| 24 | 1.00 | 0 | ||
| 48 | 2.00 | 1 | ||
| 72 | 2.00 | 0 | ||
| 7 days | 1.00 | 0 | ||
| mean (24/48/72h) | 1.67 | 0.33 | ||
| 25 | 1 | 1.00 | 1 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 5 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 1 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 3 | 100 | 1 | 1.00 | 0 |
| 24 | 2.00 | 1 | ||
| 48 | 2.00 | 1 | ||
| 72 | 2.00 | 1 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 2.00 | 1.00 | ||
| 25 | 1 | 1.00 | 0 | |
| 24 | 1.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.33 | 0.00 | ||
| 5 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 | ||
| 1 | 1 | 0.00 | 0 | |
| 24 | 0.00 | 0 | ||
| 48 | 0.00 | 0 | ||
| 72 | 0.00 | 0 | ||
| 7 days | 0.00 | 0 | ||
| mean (24/48/72h) | 0.00 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study to determine the skin irritation potential of the test substance in rabbits was conducted. It showed that the test substance is moderate irritant if applied undiluted, mild irritant in a concentration of 25 % and non-irritant with a concentration of 5 % or lower.
- Executive summary:
A skin irritation test was performed according to OECD 404 using 3 rabbits with an exposure time of 4 h. The animals were observed for 7 days. The experiment was terminated on day 7 when most effects were not detectable anymore or in clear regression. The test substance caused erythema and edema development that was reversible. The mean Primary Cutaneous Irritation Index for 24/72h was 2.3 with the undiluted test substance. A concentration of 25 % resulted in a Primary Cutaneous Irritation Index of 0.3. A concentration of 5 % as well as 1 % resulted in an index of 0.0. The erythema score for animal 1 for 24/48/72h with the undiluted test substance was 2.0 and the edema score was 0.67. The erythema score for animal 2 for 24/48/72h with the undiluted test substance was 1.67 and the edema score was 0.33. The erythema score for animal 3 for 24/48/72h with the undiluted test substance was 2.0 and the edema score was 1.0. Due to these results the test substance was found to be moderately skin irritating but without classification.
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