Registration Dossier
Registration Dossier
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EC number: 260-982-3 | CAS number: 57843-53-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from April 17, 1996 to April 25, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide
- EC Number:
- 260-982-3
- EC Name:
- N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide
- Cas Number:
- 57843-53-5
- Molecular formula:
- C18H36N2O6
- IUPAC Name:
- N,N,N',N'-tetrakis(2-hydroxypropyl)hexanediamide
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test System Rationale: New Zealand White Rabbit - Chbb:NZW(SPF)
Source: Recognized by the International guidelines as the recomended test system (e.g. EPA, OECD, EEC)
Number of animals per test: 1 male, 2 females
Age at treatment: 15 weeks
Body weight at start of acclimatization: male: 2.8 kg, females: 2.2 - 3.0 kg
Body weight at start of treatment: male: 3.1 kg; females: 2.4 - 3.1 kg
Identification: By unique cage number and corresponding ear tags.
Acclimatization: Four days under test conditions after examination. Only healthy animals were used study.
Allocation: male no. 13; female nos. 14 - 15
Conditions
Standard Laboratory Conditions.
Air-conditioned with 10 - 15 air changes per hour and continuously monitored environment with target ranges for temperature of 20 ±3 °C and for relative humidity between 40 - 70% (values above 70% during cleaning process possibly), 12 hours artificial fluorescent 12 light/12 hours dark, music during the light period.
Accommodation: Individually in stainless steel cages with an automatic equipped with feed hoppers, drinking water bowls and wood for gnawing.
Diet: Pelleted standard Kliba 341 rabbit maintenance diet (batch 93/96) ad libitum from Kliba Muhlen AG, CH-4303 Kaiseraugst), Results of analysis for contaminants are included in this report.
Water: Community tap water from Itingen, ad libitum. Results of bacteriological, chemical and contaminant analyses are included in this report.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Controls:
- other:
- Amount / concentration applied:
- 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hrs after administration
- Number of animals:
- 1 males, 2 females
- Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was clipped with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm).
The skin of the animals was examined once, 1 day prior to test article administration.
Only those animals with no signs of skin injury or irritation were used in the test.
On the day of treatment, 0.5 g of the test article was applied to approx. 6 cm² of the intact skin of the clipped area. It was covered with a 2.5 cm x 2.5 cm patch of surgical gauze. The gauze was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. The test article was applied in such a position as to preclude oral ingestion after removal of the dressing.
The duration of treatment was 4 hours.Then the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
The skin reaction was assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and test article.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritant / corrosive response data:
- The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for and they are viewed as reference values, a severe test and the results are not conditions.
irritation
PRIMID QM 1260 showed a primary irritation score of 0.11 when applied to healthy intact rabbit skin.
Local signs (mean values from 24 to 72 hours) consisted of grade 0,11 erythema and grade 0.00 edema. Erythema was noted in one animal only and was reversible after 48 hours.
CORROSION
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- Necropsy
No necropsy was performed in the animals euthanized at termination of observation.
VIABILITY / MORTALITY AND CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the test and observation period, and no mortality occurred.
COLORATION
No staining by the test article of the treated skin was observed.
BODY WEIGHTS
The body weight gain of all rabbits was within the normal range of variability.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- No test-related response was observed in the study and thus, the test substance is a non-irritant for skin of rabbits.
- Executive summary:
The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. Under the conditions of this experiment, the test material was found to cause a primary irritation score of 0.11 (max. 8.0) when applied to healthy intact rabbit skin.
Local signs (mean values from 24 to 72 hours) consisted of grade 0.11 erythema and grade 0.00 edema. The single erythema grade was reversible after 48 hours.
The test article did not cause staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any measuring interval.
Based on the available data, the test substance is not to be classified according to CLP (Regulation EC No.1272/2008) for effects to skin.
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