Registration Dossier
Registration Dossier
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EC number: 419-310-6 | CAS number: 125248-71-7
Endpoint summary
Administrative data
Description of key information
The test material was sensitizing to skin in the GPMT Assay according to OECD Guideline 406 performed under GLP conditions.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 14 until December 15, 1995
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The GPMT Assay was conducted before the LLNA Assay became mandatory.
- Species:
- guinea pig
- Strain:
- other: IVA : PDH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Kisslegg
- Age at study initiation: about 4 weeks
- Weight at study initiation: 338 to 424 g
- Housing: individually in Makrolon cages type IV (floor area: 55 x 33 cm = 1815 cm2, height: 20 cm) placed an mobile racks.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 28
- Humidity (%): 31 - 63
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 20%
- Day(s)/duration:
- Day 8/ 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5.0%
- Day(s)/duration:
- Day 22/24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 5.0%
- Day(s)/duration:
- Day 29/ 24 hoours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 5 animals per sex and per dose (negative control)
10 animals per sex and per dose (positive control) - Details on study design:
- RANGE FINDING TESTS: The follwoing concentrations were used:
1. Vehicle (intradermal): undiluted
2. Test material (intradermal): 2.5%, 1.0%, and 0.5% in liquid paraffin
3. Test material (topical): 25.0, 15.0, 10.0, and 5.0% in liquid paraffin
Based on the results of the pre-test the follwoing concentrations were used for the main test:
- intradermal induction: 0.5% (slightly irritant)
- topical induction: 20.0% (slightly irritant)
- topical challenge: 5.0% (not irritant)
MAIN STUDY
A.1 INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: six (three on each side of the spinal column)
- Test groups: FCA + phys. sodium chloride solution; 0.5% test material in liquid paraffin; FCA with test material (0.5 g ad 100 mL completed preparation) + phys. sodium chloride solution
- Control group: FCA + phys. sodium chloride solution; liquid paraffin; FCA + phys. sodium chloride solution
- Site: shoulder
- Frequency of applications: once
A.2 INDUCTION EXPOSURE (topical application)
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: 20% test material in liquid paraffin
- Control group: liquid paraffin (undiluted)
- Site: shoulder
- Frequency of applications: once
- Concentrations: 20% test material in liquid paraffin
B. CHALLENGE EXPOSURE
- No. of exposures: two
- Day(s) of challenge: first challenge on day 22; second challenge on day 29
- Exposure period: 24 hours
- Test groups: 5% test material in liquid paraffin (left side); undiluted liquid paraffin (right site)
- Control group: 5% test material in liquid paraffin (left side); undiluted liquid paraffin (right site)
- Site: flank
- Evaluation (hr after challenge): 48 and 72 hours - Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (positive control data from study T 13982 performed from Nov 14 until Dec 15, 1995)
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5.0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 5.0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5.0%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5.0%
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5.0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 5.0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5.0%
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5.0%
- No. with + reactions:
- 5
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No clinical and no mortality occurred. Body weight gain was normal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.01% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.01% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The test item is considered to be sensitizing to skin based on the results of the GLP conform study according to OECD Guideline 406.
- Executive summary:
The test item was studied for skin sensitizing properties in the guinea-pig maximization test according to OECD Guideline 406 under GLP conditions.
5 males and 5 females in the negative control group (group 1) and 10 males and 10 females in the test material group (group 2) were investigated.
Induction included intradermal injection of the test material (0.5 % without and with Freund's complete adjuvant) on day 1, and topical application of the test material (20.0 %) on day 8 of the study. Challenge by topical application of the test material (5.0%) was performed two weeks after topical induction (challenge I). Two animals of group 2 after the first challenge reacted on both sites. Therefore, a second challenge was performed (challenge II) one week later to clarify this result.
Group 1: negative control group
Following challenge I and challenge II no positive reactions in the treated areas were observed.
Group 2: test material group
With paraffin alone, 2 of 20 animals after challenge I and 3 of 20 animals after challenge II showed positive reactions. Topical challenge with the test item was performed with a 5.0 % preparation. After challenge I, positive reactions in the treated areas were observed in 7 of 20 animals (35 %). After challenge II, 10 of 20 animals (50 %) showed positive reactions.
Based on the available data, the test item has to be considered as skin sensitizer.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, the test item is classified as skin sensitizer Cat. 1 and labelled with H317 according to Regulation (EC) No 1272/2008.
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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