Registration Dossier
Registration Dossier
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EC number: 932-476-9 | CAS number: 91722-10-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: NF EN ISO 10993-10 (February 2003) concerning biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity
- Deviations:
- no
- Principles of method if other than guideline:
- Buehler test selected for sensitisation testing because substance was thought to have (slight) irritating properties by that time
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An appropriate guinea pig maximisation test/Buehler test is available which would not justify conducting an additional LLNA due to animal welfare. Also according to“Guidance on information requirements and chemical safety assessment Chapter R.7a: Endpoint-specific guidance” (ECHA, 2008) any OECD method can be used for registration.
Test material
- Reference substance name:
- Slags, steelmaking, elec. furnace (stainless(high alloy steel production - EAF S)
- IUPAC Name:
- Slags, steelmaking, elec. furnace (stainless(high alloy steel production - EAF S)
- Details on test material:
- Name Slags, steelmaking, elec. furnace (stainless(high alloy steel production - EAF S)
Appearance solid
Composition UVCB
Molecular formula not applicable (UVCB)
Molecular weight not applicable (UVCB
Purity 100 w/w % slag
Homogeneity not stated
Volatility extremely low (melting point > 300 °C)
Stability solid slag is stable at room temperature
Solubility slightly soluble in water
Date of production not stated
Date of expiry Year 2024
Storage conditions Room temperature 20 ± 5°C
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Male albino guinea pigs were supplied by CHARLES RIVER (F-69592 L’ARBRESLE). The animals were identified individually by marking with picric acid and a tattoo placed on their ear. They weighed between 252 g and 295 g at the beginning of the main test and were 4 weeks old. The animals were adapted to the test conditions for at least 5 days with the drinking water (tap water) and food were supplied ad libitum, under stabling and nutritional conditions identical to those of the test.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- The slag leachate was prepared according to DIN 38414-4 DEV-S4 (L/S 10/1) and had a nominal concentration of 100 g/L .
pH was between 7.26 and 8.56
The test extracts have been prepared at the following dates:
08 September 2009 to 09 September 2009 (pH=7.26, 22°C, colourless solution)
15 September 2009 to 16 September 2009 (pH=7.24, colourless solution)
21 September 2009 to 22 September 2009 (pH=8.56, colourless solution)
28 September 2009 to 29 September 2009 (pH=8.02, 22°C, colourless solution)
13 October 2009 to 14 October 2009 (pH=8.08, colourless solution)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- The slag leachate was prepared according to DIN 38414-4 DEV-S4 (L/S 10/1) and had a nominal concentration of 100 g/L .
pH was between 7.26 and 8.56
The test extracts have been prepared at the following dates:
08 September 2009 to 09 September 2009 (pH=7.26, 22°C, colourless solution)
15 September 2009 to 16 September 2009 (pH=7.24, colourless solution)
21 September 2009 to 22 September 2009 (pH=8.56, colourless solution)
28 September 2009 to 29 September 2009 (pH=8.02, 22°C, colourless solution)
13 October 2009 to 14 October 2009 (pH=8.08, colourless solution)
- No. of animals per dose:
- 11 controls (including 3 positive controls)
21 test animlas in total - Details on study design:
- Before each test extract application, the animals were carefully shorn before each test extract application:
- On the inter-scapular zone for the induction phase
- On the dorso-lumbar zone for the challenge phase
At least 3 h before the first reading (challenge phase) they were shorn a second time.
The animals were weighed at the beginning and at the end of the study. - Challenge controls:
- 3 males with the eference substance: α-Hexylcinnamaldehyde CAS n° 101-86-0
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Results and discussion
- Positive control results:
- the positive control is a sensitizer with 9-100 % of animals developing positive response
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 11
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 11.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 21
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 g/L. No with. + reactions: 0.0. Total no. in groups: 21.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 g/L
- No. with + reactions:
- 0
- Total no. in group:
- 21
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 g/L. No with. + reactions: 0.0. Total no. in groups: 21.0. Clinical observations: none.
Any other information on results incl. tables
No abnormalities and no differences in the body weight between the control and the treated group, no mortality, and no clinical signs
were observed in any group.
Individual results of macroscopic evaluation (readings at 24 and 48 hours) of cutaneous reactions
Animal no. controls |
100% (MNIC) 24 h Er |
100% (MNIC)24 h Oe |
100% (MNIC) 48 hEr |
100% (MNIC) 48 hOe |
50% (1/2 MNIC) 24 hEr |
50% (1/2 MNIC)24 h Oe |
50% (1/2 MNIC) 48 hEr |
50% (1/2 MNIC) 48 hOe |
2206 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2207 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2208 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2209 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2210 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2211 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2212 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2213 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2214 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2215 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2216 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Treated Group
Animal no. treated |
100% (MNIC) 24 h Er |
100% (MNIC)24 h Oe |
100% (MNIC) 48 hEr |
100% (MNIC) 48 hOe |
50% (1/2 MNIC) 24 hEr |
50% (1/2 MNIC)24 h Oe |
50% (1/2 MNIC) 48 hEr |
50% (1/2 MNIC) 48 hOe |
2217 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2218 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2219 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2220 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2221 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2222 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2223 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2224 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2225 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2226 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2227 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2228 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2229 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2230 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2231 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2232 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2233 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2234 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2235 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2236 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2237 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- EAF S: not irritating and not sensitising
- Executive summary:
The possible allergenic activity of slags, steelmaking, elec. furnace (stainless/high alloy steel production - EAF S), granular (0 -10 mm) was tested according to OECD 406 and NF EN ISO 10993-10 (February 2003) concerning biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity.
Slag leachate was prepared by DIN 38414 -4 DEV S-4 by leaching for 24 h at a liquid/solid ratio of 10/1. For induction, 21 Guinea pigs were exposed to the leachate in triplicate topical applications under occlusive dressing for 6 h at 100 % (undiluted) leachate. After a 14-day rest phase, the challenge phase consisted of a single topical application (24 h) of the leachate at 100 % and 50 % dilution in demineralised water.
No visible cutaneous reactions and no intolerance reaction was recorded in the challenge phase neither at 100 % nor at 50 %, and no reaction was recorded in the negative controls.
EAF S is not irritating and does not need to be classified as a skin sensitizer. No signal word and no hazard statement is required.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
