Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 238-056-5 | CAS number: 14205-39-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- Magnusson-Kligman Maximisation Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 November 1999 - 16 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Magnusson-Kligman Maximisation Test is one of the methods recommended by current regulatory guidelines.
Test material
- Test material form:
- solid
- Details on test material:
- Expiry date: 21 May 2000
Batch: 624
Constituent 1
- Specific details on test material used for the study:
- The test material, a white crystalline solid, was stored in the dark at ambient temperature.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Twenty one young adult (less than one year old), nulliparous and nonpregnant, female albino guinea pigs of the Dunkin-Hartley strain, within the
weight range 325-413 g on arrival were used. They were supplied by David Hall Limited, and arrived at lnveresk Research in 2 batches.
The dose ranging animals arrived on 27 October 1999, and the main study animals arrived on 5 November 1999.The animals were allowed to
acclimatise for at least 5 days prior to commencement of the study. The animals were multiply housed in aluminium cages (dimensions 48 x 61 x
25 cm) with a grid floor beneath which was an absorbent paper lined tray. The dose ranging animals were housed 2 to a cage and the main study
animals 5 to a cage. Each cage was supplied with a water bottle and a food hopper. Mean environmental maximum and minimum temperatures were
21°C and 20°C and mean relative humidity was 45% (range 27-52°C}. On three occasions the humidity was lower than the range specified on the protocol
(55%± 15%), this deviation did not affect the outcome of the study. A 12 h light/dark cycle was in operation (light hours 0700-1900 h) with a minimum of
15 air changes per hour.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- maize oil
- Remarks:
- in vehicle 1:1
- Concentration / amount:
- 4%
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 60%
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- 60%
- Day(s)/duration:
- 24 h, 48 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test group: 10
Control group: 5 - Details on study design:
- Dose levels for dose ranging for induction were a range of 6 concentrations of test material and took account of the maximum practicable concentration for administration (2% for intradermal injection and 60% for topical application).
Dose levels for dose ranging for challenge were selected based on the dose ranging for induction topical results. These were a range of 4 levels of the test material and were selected to determine the maximum non-irritant
concentration at challenge. Dose levels for induction were selected based on the dose ranging for induction and were such that necrosis or severe reactionswere not produced. Dose levels for challenge were selected based on the dose ranging for challenge results and were the highest concentration that did notcause irritation. The levels selected were the maximum practicable and were also well tolerated systemically.
- on day prior to intradermal injections hair was clipped
- on the following day six intradermal injections
- after six days hair was again clipped (no treatment with 10% SLS due to presence of irritation at dose ranging)
- on the next day topical induction (0.5 ml), patch for 48 h, occlusive
- after 13 days again hair clipped
- on the following day topical challenge, patch for 24 h, occlusive
- skin reactions were examined and graded 24 h after intradermal induction, 24 h after removal of patch of topical induction and 24 and 48 h after removal of patch of topical challenge - Challenge controls:
- Each animal was treated with test material and vehicle applied topically to the flanks under 2 Webril patches (2.5 cm x 2.5 cm).
- Positive control substance(s):
- yes
- Remarks:
- MBT
Results and discussion
- Positive control results:
- Following challenge with MBT at a dose level of 25% w/v in maize oil, 100% of the Test Group animals and none of the Control Group animals reacted positively.
These results demonstrate the ability of the test method to identify a mild/ moderate sensitiser.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Test 2 and Test 3, 5 animals per Test group
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 60%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- Test 2 and Test 3, 5 animals per Test group
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25% (MBT)
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 4 test groups, each test group with 5 animals
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 % (MBT)
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- 4 test groups, each test group with 5 animals
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
Any other information on results incl. tables
Dose ranging for challenge:
Intradermal lnjection
Discrete erythema was noted in both animals.
Topical Application
Discrete erythema was noted in both animals.
Challenge
No erythema was noted in either animal up to a concentration of 60% LZ937.
Based on this, 60% LZ937 was selected for the challenge phase.
Main Study Induction:
Intradermal lnjection
Discrete erythema was noted in all animals.
Topical Application
No erythema was noted in any of the animals. Scabbing was noted at the test sites of 4 Test Group animals.
Main Study Challenge:
Following challenge with 60% LZ937, there were 10 (100%) positive responses noted in the Test Group animals and no positive responses noted
in the Control Group animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Under the conditions of the study, LZ937 is considered to be a sensitiser in guinea pigs.
- Executive summary:
The delayed contact hypersensitivity of a test material, LZ937, was investigated by means of a Magnusson-Kligman Maximisation Test in guinea pigs.
The study was performed according to OECD 406 and GLP in year 1999. Following challenge with 60% LZ937, 10 {100%) positive responses were
noted in the Test Group animals and no positive responses were noted in the Control Group animals.
Under the conditions of the study, LZ937 is considered to be a sensitiser in guinea pigs.
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.
