Registration Dossier
Registration Dossier
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EC number: 275-809-7 | CAS number: 71662-46-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-05-09 to 1989-05-16
- 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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- EC Number:
- 275-809-7
- EC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- Cas Number:
- 71662-46-9
- Molecular formula:
- C24H38O4 - C28H46O4
- IUPAC Name:
- 1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Witamol 118
- Substance type: product
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
Test animals
- Species:
- rabbit
- Strain:
- other: Small White Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 kg
- Housing: single housing in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K4 complete feed for rabbits, ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 cm³ - Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- % coverage: not mentioned
- Type of wrap if used: on the application area a mull patch (2,5 x 2,5 cm) was placed, the application area was then immobilised with an elastic dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to OECD guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- after 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- AVERAGE SCORE
- Erythema: 1.0
- Edema: 0.0 - Other effects:
- none
Any other information on results incl. tables
Table #: Irritant/corrosive response data for each animal at each observation time of each animal from the test
Score at time point / Reversibility |
Erythema |
Edema |
Max. score: 4 |
Max. score: 4 |
|
60 min |
0/1/0 |
0/0/0 |
24 h |
1/1/1 |
0/0/0 |
48 h |
1/1/1 |
0/0/0 |
72 h |
1/1/1 |
0/0/0 |
Average 24h, 48h, 72h |
1.0 |
0 |
Reversibility*) |
c. |
- |
Average time (unit) for reversion |
7 days |
- |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters was only slightly irritating.
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