Registration Dossier
Registration Dossier
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EC number: 238-056-5 | CAS number: 14205-39-1
Endpoint summary
Administrative data
Description of key information
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.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- Specific details on test material used for the study:
- The test material, a white crystalline solid, was stored in the dark at ambient temperature.
- 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. - 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
- 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
- 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. - 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
- 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The study demonstrated a skin sensitizing potential of LZ937 therefore, LZ937 has to be classified with Skin Sens. 1; H317.
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