Registration Dossier
Registration Dossier
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EC number: 274-713-2 | CAS number: 70643-20-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- A readacross with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride is proposed. The substance detailed in section 1 and the analogue material are both salts of 2-(2,4-diaminophenoxy)ethanol with similar physical and chemical properties.
Data source
Referenceopen allclose all
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
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:
- 2-(2,4-diaminophenoxy)ethanol dihydrochloride
- EC Number:
- 266-357-1
- EC Name:
- 2-(2,4-diaminophenoxy)ethanol dihydrochloride
- Cas Number:
- 66422-95-5
- Molecular formula:
- C8H12N2O2.2ClH
- IUPAC Name:
- 2-(2,4-diaminophenoxy)ethanol dihydrochloride
- Details on test material:
- Test item : Imexine OAJ
EC number : 266-357-1
Batch number : Op. 118
Purity : 99.4%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, France
- Age at study initiation: No information available
- Weight at study initiation: 1.5-2.5kg
- Housing: Individually in cages
- Diet (e.g. ad libitum):UAR foodstuff
- Water (e.g. ad libitum): Softened tap water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 45-65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: No information available
Test system
- Type of coverage:
- other: non-occlusive dressing
- Preparation of test site:
- other: the back area of test animals was clipped free of hair
- Vehicle:
- other: right flank previously treated with 0.5 ml paraffin oil
- Controls:
- no
- Amount / concentration applied:
- 0.5g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
The day before application, the back area of test animals was clipped free of hair. A 0.5g sample of neat IMEXINE OAJ was applied to 6 cm2 of the right flank which was previously treated with 0.5 ml paraffin oil. The untreated left flank served as a control. The dressing was then removed and cutaneous reactions were assessed 1, 24, 48 and 72 hours after dressing removal.
SCORING SYSTEM
Erythema
- No erythema : 0
- Slight erythema (scarcely visible) : 1
- Clearly visible erythema : 2
- Moderate to marked erythema : 3
- Severe erythema with formation od deep lesions : 4
Edema
- No edema : 0
- Very slight edema : 1
- Slight edema (contours well defined, visible swelling) : 2
- Moderate edema (thickness ~1mm) : 3
- Severe edema (thickness more tham 1mmand area greater than that of application : 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- (cumulative)
- Score:
- 0.11
- Remarks on result:
- other: not irritating to rabbit skin
- Irritation parameter:
- erythema score
- Basis:
- other: overall at 24, 48 and 72 hours
- Time point:
- other: all animals
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: not irritating to rabbit skin
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- (cumulative)
- Score:
- 0
- Remarks on result:
- other: not irritating to rabbit skin
- Irritation parameter:
- edema score
- Basis:
- other: all animals
- Time point:
- other: overall at 24, 48 and 72 hours
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: not irritating to rabbit skin
- Irritant / corrosive response data:
- There were no cutaneous reactions apart from a slight erytherma observed in 1 animal at the 48 hour observation only.
Any other information on results incl. tables
There were no cutaneous reactions apart from a slight erytherma observed in 1 animal at the 48 hour observation only.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. When tested undiluted, IMEXINE OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) was not irritating to the rabbit skin.
- Executive summary:
For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. The skin irritation potential of the substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride was assessed according to OECD guideline 404 in compliance to GLP. The day before application, the back area of test animals was clipped free of hair. A 0.5g sample of neat IMEXINE OAJ was applied to 6 cm2 of the right flank which was previously treated with 0.5 ml paraffin oil. The untreated left flank served as a control. The dressing was then removed and cutaneous reactions were assessed 1, 24, 48 and 72 hours after dressing removal. There were no cutaneous reactions apart from a slight erytherma observed in 1 animal at the 48 hour observation only. When tested undiluted, IMEXINE OAJ (2-(2,4-diaminophenoxy)ethanol dihydrochloride) was not irritating to the rabbit skin.
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