Registration Dossier
Registration Dossier
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EC number: 907-605-7 | CAS number: 68815-47-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (short-term test)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 1981
- Deviations:
- yes
- Remarks:
- short exposure periods (3 m/ 1 h)
- GLP compliance:
- no
Test material
- Reference substance name:
- bis(6-aminohexyl)amine; hexane-1,6-diamine
- EC Number:
- 907-605-7
- Cas Number:
- 68815-47-4
- Molecular formula:
- C6H16N2 (HMD) C12H29N3 (BHT)
- IUPAC Name:
- bis(6-aminohexyl)amine; hexane-1,6-diamine
- Details on test material:
- - Name of test material (as cited in study report): Bis-hexamethylenetriamine Mixture
- Physical state: solid, dark blue
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach, D
- Weight at study initiation: 2.30 kg
- Housing: individually in cages of stainless steel with wire mesh walk floors, 40*51 cm
- Diet (e.g. ad libitum): Kliba 341, 4 mm, Klingenthalmuehle AG, Kaiseraugst, CH; ca. 130 g/d
- Water (e.g. ad libitum): tap water, ca 250 mL/d
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS in fully air-conditioned rooms
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin sites
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 3 min, 1 h
- Observation period:
- 72 h
- Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm *2.5 cm on the upper third of the back or flanks
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
SCORING SYSTEM: OECD Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 3 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: full thickness necrosis already observed after 3 min exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- 3 min exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- 1 h exposure
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: full thickness necrosis already observed after 1 h exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 1 h exposure
- Time point:
- other: 24 - 48 -72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was found to be corrosive when applied undiluted to intact skin of rabbits for either 3 minutes or one hour under semiocclusive conditions.
- Executive summary:
The primary skin irritation potential of the test item was investigated similar to OECD test guideline no 404 using shorter exposure periods as described for potentially corrosive matter.
The test item (0.5 mL) was applied to the intact skin of one New Zealand White rabbit under semiocclusive conditions for either 3 minutes or one hour. The scoring of skin reactions was performed at 24, 48 and 72 hours.
Skin reactions observed after 3 minutes of exposure already revealed necrotic effects within the full thickness of skin. Moreover mean (i.e. 24 -48 -72 h reading times) erythema score of 4 (i.e. maximal possible score) as well as a mean edema score of 1 was reported. After 1 hour exposure necrosis was observed, too. Mean erythema score of 4.0 and mean edema score of 2.0 was reported. All of the described effects were not reversible within 72 hours. Due to the severity of effects and irreversibility seen the test item was regarded as corrosive to skin of rabbits.
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