Registration Dossier
Registration Dossier
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EC number: 810-418-2 | CAS number: 1703784-30-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- EC Number:
- 810-418-2
- Cas Number:
- 1703784-30-8
- IUPAC Name:
- Reaction products of acrylonitrile and 2,2’-Iminodi(ethylamine), hydrogenated
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species / Strain Rabbit / New Zealand White
Supplier Thomas Bauer Kaninchenzucht, Neuenstein
Germany
Selection of species The rabbit is a commonly used non-rodent spe-cies for acute dermal irritation/corrosion tests (patch test).
Sex Female animal
Number of animals 1
Age (at dosing) Approx. 5 months
Body weight At dosing
Animal no. 1: 4.4 kg
Termination of test
Animal no. 1: 4.3 kg
Identification of animals By tattooed number
Duration of study 46 adaptation days and 1 test day; the study was terminated on test day 2
Animals were individually housed in cages measuring 660 mm x 823 mm x 500 mm (Scanbur, Denmark) at a room temperature of 20°C ± 3°C (maximum range) and relative humidity of 30% - 70% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
The rooms were lit (about 150 lux at approx. 1.5 m room height) and darkened on a 12-hour light/12-hour dark cycle.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 24 h
- Number of animals:
- 1
- Details on study design:
- Route of administration: Dermal application onto the shaved, intact dorsal skin.
Approximately 24 hours before the test, the fur was removed by closely clipping the dorsal area of the trunk of the animals. Care was taken to avoid abrading the skin. Only animals with healthy intact skin were used.
A dose of 0.5 mL of the test item was applied to the test site (area: approx. 6 cm2).
The test item was applied to the test site and then covered with a gauze patch. The patch was loosely held in contact with the skin by means of a suitable semi-occlusive dressing for the duration of the exposure period. The surrounding untreated skin served as a control.
Exposure time was 4 hours.
Suspected corrosive / irritating test items
Initial test using one animal
Three test patches were applied sequentially to the animal. The first patch was removed after three minutes. As no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour. No skin reactions were observed, neither. So, a third patch was applied and removed after 4 hours. Immediately after removing this third patch an erythema grade 1 was observed at the administration site. One hour after patch removal this administration site showed an erythema grade 4 and necrosis. These findings were also observed 24 hours after patch removal. Hence, the study was terminated due to this corrosive effect. No further animal was tested.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 4
- Remarks on result:
- other:
- Remarks:
- Immediately after end of the 4-hour exposure period (patch no. 3) the corresponding application site showed an erythema grade 1. One hour and 24 hours after patch removal an erythema grade 4 and necrosis were observed. Hence, the study was terminated due to this corrosive effect. No further animal was tested.
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Immediately after end of the 4-hour exposure period (patch no. 3) the corresponding application site showed an erythema grade 1. One hour and 24 hours after patch removal an erythema grade 4 and necrosis were observed. Hence, the study was terminated due to this corrosive effect. No further animal was tested.
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Remarks:
- Immediately after end of the 4-hour exposure period (patch no. 3) the corresponding application site showed an erythema grade 1. One hour and 24 hours after patch removal an erythema grade 4 and necrosis were observed. Hence, the study was terminated due to this corrosive effect. No further animal was tested.
- Irritant / corrosive response data:
- Immediately after end of the 4-hour exposure period (patch no. 3) the corresponding application site showed an erythema grade 1. One hour and 24 hours after patch removal an erythema grade 4 and necrosis were observed. Hence, the study was terminated due to this corrosive effect. No further animal was tested.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1C (corrosive) based on GHS criteria
- Conclusions:
- According to the Globally Harmonized System (GHS) and EC-Regulation 1272/2008 and subsequent regulations, the test item is classified as category 1C: Skin corrosive
- Executive summary:
Under the present test conditions, one rabbit exposed for 4 hours to 0.5 mL PU-2018-821/patch (semi-occlusive conditions) revealed following effect:
Immediately after end of the 4-hour exposure period (patch no. 3) the corresponding application site showed an erythema grade 1. One hour and 24 hours after patch removal an erythema grade 4 and necrosis were observed. Hence, the study was terminated due to this corrosive effect. No further animal was tested.
Three-minute (patch no. 1) or 1-hour (patch no. 2) exposure to the test item did not reveal any changes.
There were no systemic intolerance reactions.
According to the Globally Harmonized System (GHS) and EC-Regulation 1272/2008 and subsequent regulations, the test item is classified as category 1C: Skin corrosive
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