Registration Dossier
Registration Dossier
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EC number: 292-550-5 | CAS number: 90640-32-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, hydrogenated tallow alkyl
- EC Number:
- 262-976-6
- EC Name:
- Amines, hydrogenated tallow alkyl
- Cas Number:
- 61788-45-2
- IUPAC Name:
- 61788-45-2
- Reference substance name:
- Hydrogenated Tallow Alkylamines
- IUPAC Name:
- Hydrogenated Tallow Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Farmin TH
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 2.0-2.2 kg
- Housing: were housed individually in stainless steel cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21 ºC
- Humidity (%): 47-67%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g (moistened with water) - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30-60 minutes and 24, 48 and 72 hours as well as 7 and 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure:4 hours
SCORING SYSTEM:
Erythem and eschar formation
0 No erythema
1 Very slight erythema (barely perceptible)
2 Well defined erythema
3 Moderate to severe erythema
4 Severe erythema (beet redness) to slight eschar formation (injuries in depth)
Edema formation
0 No edema
1 Very slight edema (barely perceptible)
2 Slight edema (edges af area well defined by definite raising)
3 Moderate edema (raising approximately 1 mm)
4 Severe edema (raised more than 1 mm and extending beyond area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: exposure 4 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h / 48h / 72h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: exposure 4 hours
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the study results, the test material Farmin TH is considered to be irritating to skin.
- Executive summary:
In an OECD TG 404 study the test substance Farmin TH (hydrogenated tallow alkyl amine), a white solid (pH = 9.93, purity 95%), was applied semi-occlusively for 4 hours to the shaved skin of three New Zealand White Rabbits. 0.5 g of the test substance, wetted with water, were applied on 2.5 cm2surgical gauze and applied to the shaved backs of the rabbits. Average scores for erythema were 2.0 (24 hours), 2.0 (48 hours) and 2.0 (72 hours). Scores for oedema were 1.3, 0.7 and 1.3 for the same time points. Whereas oedema reactions were reversible within 72 hours, erythema were still present after 7 days and reversed within 14 days.
The degree of skin irritation caused by the substance was determined after it was applied to shaved rabbit skin, under semi-occlusive patch, and left for 4 hours. The reaction on the test zone was evaluated approximately 30 -60 minutes and 24, 48 and 72 hours after the end of the exposure period. Additional observations were carried out after 7 and days to check the reversibility of the observed reactions. The substance is considered IRIITANT to the skin and it will have to be labelled with the notation of risk R38.
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