Registration Dossier
Registration Dossier
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EC number: 251-073-2 | CAS number: 32509-66-3
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 Mar - 6 Mar 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed in analogy to current OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 h exposure, 72 h observation period
- Qualifier:
- according to guideline
- Guideline:
- other: according to method: §1500.41 Federal register 38, No. 187, 27.09.1973, p 27019.
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
Test material
- Reference substance name:
- Hostanox O 3
- IUPAC Name:
- Hostanox O 3
- Reference substance name:
- DTB glycol ester
- IUPAC Name:
- DTB glycol ester
- Details on test material:
- White powder
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG own breed (Hoe:HIMK (SPFWiga)
- Weight at study initiation: 1.9-2.3 kg
- Housing: single cages
- Diet (e.g. ad libitum): ERKA 8300 (Futtermittelwerk Robert Koch oHG, Hamm/Westf.) ad libitum
- Water (e.g. ad libitum): ad libitum
IN-LIFE DATES: From: 3 March To: 6 March 1980
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: moistened with sesame oil (test no.1) or PEG 400 (test no.2)
- Controls:
- not required
- Amount / concentration applied:
- Two tests each performed with 500 mg Hostonx O 3
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 hours post application
48 hours post application
72 hours post application - Number of animals:
- Two tests performed with 6 rabbits each
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100 %
The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Hansamed). The plaster was fixed to the prepared skinarea (ca. 18 cm2) and then covered with a occlusive polyethylene foil and further fixed with an elastic bandage.
SCORING SYSTEM:
Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4
Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 1- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal: 7; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 8; mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: 9; mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: 10; mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal: 11; mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal: 12; mean
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all 7-12 animals
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 1-6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal: 7; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 8; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 9; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 10; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 11; mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 12; mean
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all 7-12 animals
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 1
- Irritant / corrosive response data:
- Test 1 in sesame oil (animal number 1-6):
Erythema score: mean all 6 animals (24, 48, 72h): 0.8
Edema score: mean all 6 animals (24, 48, 72h): 0.17
Test 2 in PEG 400 (animal number 7-12):
Erythema score: mean all 6 animals (24, 48, 72h): 0.8
Edema score: mean all 6 animals (24, 48, 72h): 0.1
Any other information on results incl. tables
1. Irritation scores (Vehicle: Sesame oil)
Time post appl. |
24 h |
48 h |
72 h |
|||||||||||||||
Animal number |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
1 |
2 |
3 |
4 |
5 |
6 |
Erythema score |
2 |
2 |
1 |
0 |
0 |
1 |
2 |
2 |
1 |
0 |
1 |
0 |
1 |
2 |
0 |
0 |
0 |
0 |
Oedema score |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2. Irritation scores (Vehicle: PEG 400)
Time post appl. |
24 h |
48 h |
72 h |
|||||||||||||||
Animal number |
7 |
8 |
9 |
10 |
11 |
12 |
7 |
8 |
9 |
10 |
11 |
12 |
7 |
8 |
9 |
10 |
11 |
12 |
Erythema score |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
1 |
1 |
1 |
2 |
2 |
0 |
0 |
1 |
1 |
1 |
2 |
Oedema score |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Hostanox O 3 was tested for its skin irritant properties in 6 Himalayan rabbits. The study was performed according to OECD Guideline 404. Deviations were the absence of the recovery period of 14 days and a prolonged exposure period (24 hours). These conditions make the study design more rigid compared to the regarding OECD Guideline.
With reference the reported scores and the reported trend to decreasing severity of effects within 72 h Hostanox O 3 does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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