Registration Dossier
Registration Dossier
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EC number: 943-728-2 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD 404 and GLP compliance study (from ECETOC TR 066 statment)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde
- EC Number:
- 943-728-2
- Molecular formula:
- C9H14O
- IUPAC Name:
- Reaction mass of 3,5-dimethylcyclohex-3-ene-1-carbaldehyde and 2,4-dimethylcyclohex-3-ene-1-carbaldehyde
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: unspecified
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: flank
- Vehicle:
- other: undiluted
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 1 day, 2 day, 3 day and 7 days
- Number of animals:
- 4 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 3 and 4 (individual mean)
- Time point:
- other: 24 hr, 48 hr and 72 hr
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 hr, 48 hr and 72 hr
- Score:
- 2.2
- Max. score:
- 2.5
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 hr, 48 hr and 72 hr
- Score:
- 0.83
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal: 2 and 3 (individual mean)
- Time point:
- other: 24 hr, 48 hr and 72 hr
- Score:
- 1.2
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 hr, 48 hr and 72 hr
- Score:
- 1.5
- Max. score:
- 2
- Other effects:
- Desquamation from the skin was observed in 2/4 animals at the 7 day timepoint.
Any other information on results incl. tables
Table. 2 The observed results of skin irritation
| Observation interval (days) | ||||||
| Animal No. | 1 | 1hr | 1d | 2d | 3d | 7d |
| Erythema | 2 | 2 | 2 | 2 | 1 | |
| Oedema | 0 | 1 | 1 | 0.5 | 0 | |
| Observations | De* | |||||
| Animal No. | 2 | |||||
| Erythema | 1 | 2 | 2 | 2.5 | 1.5 | |
| Oedema | 2 | 1 | 1.5 | 1 | 0.5 | |
| Animal No. | 3 | |||||
| Erythema | 2 | 2 | 2 | 2 | 1.5 | |
| Oedema | 2 | 1.5 | 1 | 1 | 0.5 | |
| Animal No. | 4 | |||||
| Erythema | 2 | 2 | 2 | 2 | 2 | |
| Oedema | 2 | 2 | 1.5 | 1 | 0.5 | |
| Observations | De* | |||||
| De*= Marked desquamation from the skin | ||||||
| PRIMARY IRRITATION INDEX = (SUM ERYTHEMA 24/48/72 hr + SUM OEDEMA 24/48/72 hr)/(3*No. Of animals) = 3.21 | ||||||
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The test substanceTrigustral was irritating to the skin of rabbits.
- Executive summary:
In a skin irritation study (ECETOC Technical Report No.066), 4 rabbits were dermally exposed (semi-occlusive) to 0.5 mL of undiluted Trigustral for 4 hrs. Animals were observed for 1 hr, 24 hr, 48 hr, 72 hr and 7 days after patch removal. Erythema and edema were scored using the grading scale for skin irritation effects noted in Table 1.
The test substance caused well defined erythema in all treated animals (mean score: 2 – 2.2), slight oedema (mean score:1 - 2 ) in 3/4 rabbits and very slight oedema (mean score: 0 - 1) in 1/4 rabbit. The odema in 1 rabbit was fully reversible on Day 7 while 3/4 animals had very slight oedema remaining (max score:0.5) at Day 7. All animals had erythema still present by Day 7 (max score:2). Desquamation from the skin was observed in 2/4 animals at the 7 day timepoint.
Trigustral is a skin irritant based on the results of this OECD 404 skin irritation/corrosion study.
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