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EC number: 943-066-4 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Endpoint summary
- Stability
- Biodegradation
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin sensitization
The sensitization rate of CJ305 was 18% and CJ305 caused mild sensitization in guinea pigs (OECD TG406).
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:
- From October 31, 2016 to March 30, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The guinea pig maximization test (GPMT) is already available for the registration outside of EU. Therefore, LLNA is not conducted.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- - Source: National Laboratory Animal Center, Taipei, Taiwan
- Age: approximately 5 to 7 weeks
- Weight at study initiation: 323-397 g
- Housing: Every two animals were housed in a stainless steel wire mesh cage
- Acclimation period: 8 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12-hrs dark / 12-hrs light - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Remarks:
- Water for injection (WFI)
- Concentration / amount:
- 0.1m L 3% and 0.4mL 50% of CJ305 for intradermal and epicutaneous, respectively
- Day(s)/duration:
- Day0 and Day 7 for intradermal and epicutaneous, respectively
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Remarks:
- Water for injection (WFI)
- Concentration / amount:
- 0.2mL 2.5% of CJ305
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- For control group: five
For treated group: twelve - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde (HCA)
- Positive control results:
- The latest results showed that positive control animals had shown maximum skin reactions of 2 and the sensitization rate of α-Hexylcinnamaldehyde (HCA) was 60%.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.2 mL 2.5% of CJ305
- No. with + reactions:
- 2
- Total no. in group:
- 11
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 406 test method and “Magnusson and Kligman Maximization Grading”, the sensitization rate of CJ305 was 18% and CJ305 caused mild sensitization in guinea pigs. Therefore, CJ305 was not met classification on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65316010-IR which is based on the SOP for the OECD 406 (CTPS-TE00516) and OECD 406 (OECD, 1992). The results of this OECD 406 test for CJ305 show that test reliability criteria was met.
A 3% and 50% CJ305 was used for intradermal injection and occlusively patched, respectively, to 12 test guinea pigs to induce sensitization. The water for injection was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 2.5% CJ305. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. One treated animal was found dead on Day 4. The probable cause of death was congenital heart abnormalities and considered to be not test article-related. At the end of study, body weight increase was observed in all surviving animals. During 48 hours after challenge exposure, two of eleven (18%) treated animals showed sensitization to the CJ305. Under the conditions of this study, CJ305 caused mild sensitization in guinea pigs.
Reference
Group #1: Control group
Group #2: Treated group
Table 1. Individual Body Weight and Clinical Observations
Animal# |
Group # |
Body Weight (g) |
Observation |
|
Day 0 |
Day 24 |
D0-24 |
||
01 |
1 |
343 |
455 |
Normal |
02 |
1 |
357 |
467 |
Normal |
03 |
1 |
371 |
416 |
Normal |
04 |
1 |
337 |
405 |
Normal |
05 |
1 |
334 |
420 |
Normal |
06 |
2 |
334 |
419 |
Normal |
07 |
2 |
333 |
416 |
Normal |
08 |
2 |
369 |
467 |
Normal |
09 |
2 |
349 |
434 |
Normal |
10 |
2 |
427 |
- |
D0-2 Normal D3 Labor breath with some yellow-colored nasal discharge. Lateral recumbency in the cage. Cynosis. D4 Found dead |
11 |
2 |
365 |
431 |
Normal |
12 |
2 |
369 |
488 |
Normal |
13 |
2 |
335 |
419 |
Normal |
14 |
2 |
323 |
407 |
Normal |
15 |
2 |
333 |
440 |
Normal |
16 |
2 |
371 |
507 |
Normal |
17 |
2 |
397 |
461 |
Normal |
#10 was found dead on D4.
Table 2. Individual Skin Reaction on Induction Sites
Animal# |
Group # |
Site |
Maximum score (Erythema / Edema) |
||||||
Study Day |
|||||||||
3 |
7 |
10 |
14 |
17 |
21 |
24 |
|||
01 |
1 |
ID_1 |
0/2 |
4/2 |
4/3 |
4/3 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/3 |
2/3 |
2/3 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/3 |
4/3 |
4/3 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/3 |
2/3 |
2/2 |
2/2 |
2/2 |
||
02 |
1 |
ID_1 |
0/2 |
4/2 |
4/3 |
4/3 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/3 |
2/3 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
3/2 |
4/3 |
4/3 |
4/3 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/3 |
2/3 |
2/2 |
2/2 |
2/2 |
||
03 |
1 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
04 |
1 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
3/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
05 |
1 |
ID_1 |
2/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
3/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
06 |
2 |
ID_1 |
0/2 |
4/2 |
4/3 |
4/3 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/3 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/3 |
2/3 |
2/2 |
2/2 |
2/2 |
||
07 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
NA/NA |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/3 |
2/3 |
2/2 |
2/2 |
2/2 |
||
08 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
NA/NA |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
09 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
3/2 |
3/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
10 |
2 |
ID_1 |
0/0 |
- |
- |
- |
- |
- |
- |
ID_2 |
0/0 |
- |
- |
- |
- |
- |
- |
||
ID_3 |
0/1 |
- |
- |
- |
- |
- |
- |
||
Topical |
- |
- |
- |
- |
- |
- |
- |
||
11 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
NA/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
NA/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
12 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
NA/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
1/2 |
1/2 |
2/2 |
2/2 |
2/2 |
||
13 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
0/2 |
1/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
1/2 |
1/2 |
2/2 |
2/2 |
2/2 |
||
14 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/3 |
4/3 |
4/2 |
ID_2 |
0/0 |
2/2 |
NA/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
3/2 |
4/2 |
4/2 |
4/2 |
4/3 |
4/3 |
4/2 |
||
Topical |
- |
- |
NA/2 |
2/2 |
2/3 |
2/3 |
2/2 |
||
15 |
2 |
ID_1 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
ID_2 |
0/0 |
2/2 |
NA/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
ID_3 |
0/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
||
Topical |
- |
- |
NA/2 |
2/2 |
2/2 |
2/2 |
2/2 |
||
16 |
2 |
ID_1 |
2/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
- |
ID_2 |
1/0 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
- |
||
ID_3 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
- |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
- |
||
17 |
2 |
ID_1 |
2/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
- |
ID_2 |
1/0 |
0/0 |
2/2 |
2/2 |
2/2 |
2/2 |
- |
||
ID_3 |
2/2 |
4/2 |
4/2 |
4/2 |
4/2 |
4/2 |
- |
||
Topical |
- |
- |
2/2 |
2/2 |
2/2 |
2/2 |
- |
-: no observation was conducted
Table 3. Individual Sensitization Observation
Animal# |
Group # |
Score |
|
24h |
48h |
||
01 |
1 |
0 |
0 |
02 |
1 |
0 |
0 |
03 |
1 |
0 |
0 |
04 |
1 |
0 |
0 |
05 |
1 |
1 |
0 |
06 |
2 |
1 |
2 |
07 |
2 |
1 |
1 |
08 |
2 |
1 |
1 |
09 |
2 |
1 |
1 |
10 |
2 |
- |
- |
11 |
2 |
1 |
1 |
12 |
2 |
1 |
0 |
13 |
2 |
2 |
3 |
14 |
2 |
1 |
1 |
15 |
2 |
1 |
0 |
16 |
2 |
1 |
1 |
17 |
2 |
1 |
1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A 3% and 50% CJ305 was used for intradermal injection and occlusively patched, respectively, to 12 test guinea pigs to induce sensitization. The water for injection was used for similar injection and occlusively patched to five control guinea pigs. Following a recovery period, animals received a challenge patch with 2.5% CJ305. The skin sensitization reactions were scored at approximately 24 and 48 hours after patch removal. One treated animal was found dead on Day 4. The probable cause of death was congenital heart abnormalities and considered to be not test article-related. At the end of study, body weight increase was observed in all surviving animals. During 48 hours after challenge exposure, two of eleven (18%) treated animals showed sensitization to the CJ305. Under the conditions of this study, CJ305 caused mild sensitization in guinea pigs.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Some sulphonated azo dyes are self-classified as Resp Sens 1, but there is no evidence of respiratory sensitisation; the classification is considered to be precautionary in some cases where there is a high respirable dust content and a classification as a potential for skin sensitisation
Justification for classification or non-classification
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