Registration Dossier
Registration Dossier
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EC number: 944-280-0 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989-08-29 to 1989-09-18
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The reliability of the original study used in Read Across is 1. Justification for Read Across is given in Section 13 of IUCLID.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01 - BB 041
- IUPAC Name:
- Similar Substance 01 - BB 041
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Dr. K. Thomae GmbH Chemisch-pharmazeutscieh Fabrik D-7950 Biberach/Riss.
- Acclimatisation period: at least 5 days.
- Housing: one animal per cage at 20 ± 3 °C, 30-70 % relative humidity and 12 hours light cycle day.
- Diet: ad libitum Standard rabbit pellet - Nafag No. 814, Gossau, Switzerland.
- Water: ad libitum.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 g of test substance applied
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- 3 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 12-16 cm².
- % coverage: full.
- Type of wrap if used: covered with aluminum foil (approx. 36 cm2) and held in place with adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
REMOVAL OF TEST SUBSTANCE
- Washing: not specified.
- Time after start of exposure: 4 hours.
SCORING SYSTEM:
- Method of calculation: Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 0
- Remarks on result:
- not determinable
- Remarks:
- due to colouration of the skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The indiviual scores are presented in Table 1 (see box "Any other information on results incl. tables"). No erythema scores according to Draize were awarded due to colouration of the skin by the test substance for the first 24 hours. From 48 hours to 72 hours no reactions were observed.
Any other information on results incl. tables
Table 1: Individual skin reaction score
|
Erythema |
Edema |
||||
Animal number |
660/F CF/TF |
954/F CF/TF |
976/F CF/TF |
660/F CF/TF |
954/F CF/TF |
976/F CF/TF |
After 1 h |
0/* |
0/* |
0/* |
0/0 |
0/0 |
0/0 |
After 24 h |
0/* |
0/* |
0/* |
0/0 |
0/0 |
0/0 |
After 48 h |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
After 72 h |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Mean 24-72 h |
0/0# |
0/0# |
0/0# |
0/0 |
0/0 |
0/0 |
CF= control flank TF = test flank
M = male F = female
* = dark blue staining # = mean 48 - 72 hours
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified as skin irritant according to the CLP Regulation (EC) No.1272/2008
- Conclusions:
- In the acute dermal irritation/corrosion study according to OECD 404 the test item is considered to be non-irritating to the skin.
- Executive summary:
In a primary dermal irritation study, three female New Zealand White rabbits (approx. 12 -14 weeks old, 2160 - 2990 g) were dermally exposed to 0.5 g of the test item on a moistened gauze patch to the shaved flank. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 72 hours. Irritation was scored by the method of Draize.
In this study, the test item is not a dermal irritant.
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