Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 13, 2018 to April 25, 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: GB/T 21609-2008 Chemicals -Test method of acute eye irritation/corrosion
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts
- Cas Number:
- 2210238-42-7
- IUPAC Name:
- Sulfonic acids, C16-alkane hydroxy and C16-alkene, potassium salts
- Test material form:
- solid
- Remarks:
- This solid sample was obtained from the original liquid form by removing water.
- Details on test material:
- CAS number: 2210238-42-7
Constituent 1
- Specific details on test material used for the study:
- -Storage conditions
Store container tightly closed in well-ventilated place. Store in corrosive resistant container with a resistant inliner. Store locked up. Don't store with acids.
-Test item stability under storage conditions
Stable in container after opening. Stable in water and in light. Stability in soil is not applicable.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
4 male healthy adult white New Zealand rabbits with 2.2-2.5 kg body weight which purchased from ChangSha TianQin Biotechnology Co. Ltd. The number of the manufacturing license:
SCXK(Xiang)2014-0010. The animals were acclimated to the laboratory accommodation for 5 days before commencement of the exposure.
All of the feeds were supplied by ChangSha TianQing biotechnology Ltd. The number of the manufacturing license: SCXK(Xiang)2014-0010.
The animals were housed in conventional environment. The temperature of the experimental animal room was 21- 23℃ and the relative humidity was 44-60 percent. The used license NO. of the experimental animal room: SYXK(Xiang)2017-0001.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- About 100 mg of the test substance was applied on the cornea.
- Observation period (in vivo):
- The eyes were examined at 1h, 24h, 48h, 72h and during the 4th to 21st day, and the scores were recorded.
- Number of animals or in vitro replicates:
- 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: day 21
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 21
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3,#4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No irritation of iris was found.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: day 21
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: day 21
- Irritant / corrosive response data:
- The detail was shown in table 2.
After 1 h exposure to the test substance, bright red hyperaemic blood vessels and obvious edemas were observed in conjunctiva of the 4 animals. After 24h exposure to the test substance, diffuse nubecula and more conjunctival secretions than normal were observed in the experimental animals. The nubecula of 1 animal aggravated from the 7th day and had not yet completely recovered at the 21st day. The eye irritations of other 3 animals were alleviated at 48h after exposure to the test substance, and all recovered during the 4th to the 21st day. No irritation of iris was found during the observation period.
Any other information on results incl. tables
Table 1 Body weights changes of acute eye irritation/corrosion test of C16K
No. | Sex | Body weight before exposure(kg) | Body weight before exposure(kg) |
1 | Male | 2.3 | 2.6 |
2 | Male | 2.5 | 2.8 |
3 | Male | 2.4 | 2.7 |
4 | Male | 2.2 | 2.5 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- According to the GB/T 21609-2008 Chemicals-Test method of acute eye irritation/corrosion, C16K had severe irritation to the rabbit eye.
- Executive summary:
The body weights of animals increased at the end of the test.
After 1h exposure to the test substance, bright red hyperaemic blood vessels and obvious edemas were observed in conjunctiva of the 4 animals. After 24h exposure to the test substance, diffuse nubecula and more conjunctival secretions than normal were observed in the experimental animals. The nubecula of 1 animal aggravated from the 7th day and had not yet completely recovered at the 21st day. The eye irritations of other 3 animals were alleviated at 48h after exposure to the test substance, and all recovered during the 4th to the 21st day. No irritation of iris was found during the observation period.
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