Registration Dossier
Registration Dossier
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EC number: 221-975-0 | CAS number: 3302-10-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-06-24 to 1986-07-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was performed according to guideline OECD 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,5,5-trimethylhexanoic acid
- EC Number:
- 221-975-0
- EC Name:
- 3,5,5-trimethylhexanoic acid
- Cas Number:
- 3302-10-1
- Molecular formula:
- C9H18O2
- IUPAC Name:
- 3,5,5-trimethylhexanoic acid
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report): Isononansäure
Charge 1155 from 1985-11-19, not specified isomer mixture, purity 99,7% with 0.25-0.3% main impurities
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Small White Russian, Chbb-SPF
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Weight at study initiation: 1.97-2.07 kg
- Housing: individual in cages
- Diet: K4 Alleindiät für Kaninchen, Ssniff Spezialfutter, Soest, Germany, ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 60 +/- 5
- Air changes (per hr): 15-fold
- Photoperiod (hrs dark / hrs light): 12 h/12 h
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 h
- Observation period:
- Examination of effects was performed 1, 24, 48 and 72 h, 6, 8, 10 and 14 days after end of exposure.
- Number of animals:
- 3 males
- Details on study design:
- Areas of about 10 x 10 cm were shaved at dorsal and lateral patrs of the body 24 h prior to exposure.
0.5 ml were applicated to areas of about 6 cm2, occluded by a plaster and polyethelyene foil.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1-72 h
- Score:
- 5.67
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: individual scores (24-48-72 h): 3.0, 3.0, 3.0, calculated from the result data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- other: individual scores (24-48-72 h): 2.67, 3.67, 2.67, calculated from the result data
- Irritant / corrosive response data:
- There was erythema as well as edema formation , accompanied by yellow-brown discolouration and hardening of the application sites. Eschars persisted until day 14, and began to peel off from day 10 on (details see below).
Any other information on results incl. tables
| Animal No. | Er, 1 h | Ed, 1h | Er, 24 h | Ed, 24 h | Er, 48 h | Ed, 48 h | Er, 72 h | Ed, 72 h |
| 1 | 3 | 2 | 3 | 2 | 3 | 3 | 3 | 3 |
| 2 | 3 | 1 | 3 | 4 | 3 | 4 | 3 | 3 |
| 3 | 3 | 2 | 3 | 3 | 3 | 3 | 3 | 2 |
Er: erythema score, Ed: edema score
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the test substance was irritating to the skin of rabbits.
- Executive summary:
Rabbits were exposed for 4 h under occlusive conditions to 0.5 mL of the test item in a skin irritation test according to OECD TG 404 (Hüls AG, 1986). At the end of the exposure period and at the 24 -48 -72 hour reading there was erythema as well as edema formation, accompanied by yellow-brown discolouration and hardening of the application sites. Mean 24 -48 -73 h erythema and edema scores were 3 and 3, respectively. Eschars persisted until day 14, and began to peel off from day 10 on.
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