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EC number: 203-208-1 | CAS number: 104-50-7
Endpoint summary
Administrative data
Description of key information
Read-across from hexan-4-olide - Skin sensitisation (in vivo): Not sensitisting (equivalent or similar to OECD406/GLP)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the below Attached justification.
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 97.4 to 3% in challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: test group. Dose level: 97.4% to 3% in challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 97.4 to 3% in challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: test group. Dose level: 97.4 to 3% in challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: No specific information provided
- Group:
- positive control
- Dose level:
- No specific information provided
- Remarks on result:
- other: No specific information provided
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material, hexan-4-olide, is not classified as skin sensitiser under the test conditions.
- Executive summary:
In a dermal sensitization study (0214-3) with hexan-4-olide (97.4%) in physiological saline, young female Hartley albino guinea pigs were tested in a maximisation test. For induction, 3% hexan-4-olide in physiological saline (intradermal injections) and undiluted hexan-4-olide in physiological saline (topical application) was used. For challenge, 3, 5, 10, 30, 50% and undiluted hexan-4-olide in water was used for topical application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. The positive control was 2,4-dinitrochlorobenzene.
The positive control, 2,4-dinitrochlorobenzene, gave the appropriate response. No positive reactions were evident after the first challenge application at 24 or 48 hours, neither when treated with physiological saline alone nor when treated with 3, 5, 10, 30, 50% and undiluted test article dilutions.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2002-04-26 to 2002-09-20
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Read-across
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed in 2002.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Japan SLC, Inc.
- Age at study initiation: 5 weeks old
- Weight at study initiation: 297 to 328 g (preliminary study), 276 to 345 g (main study)
- Housing: 5 amimals / cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/-2
- Humidity (%): 50+/-10
- Air changes (per hr): 17 times/hr
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr
IN-LIFE DATES: From: 2002-05-07 To: 2002-06-13 - Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal induction: 3.08% (Act. 3%).
Epicutaneous induction: undiluted (Act. 97.4%).
Challenge: undiluted (Act. 97.4%), 51.33% (Act. 50%), 30.80% (Act. 30%), 10.27% (Act. 10%), 5.13% (Act. 5%), 3.08% (Act.3%). - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- Intradermal induction: 3.08% (Act. 3%).
Epicutaneous induction: undiluted (Act. 97.4%).
Challenge: undiluted (Act. 97.4%), 51.33% (Act. 50%), 30.80% (Act. 30%), 10.27% (Act. 10%), 5.13% (Act. 5%), 3.08% (Act.3%). - No. of animals per dose:
- 5 females for intradermal treatment in preliminary study.
5 females for epicutaneous (occlusive) treatment in preliminary study.
10 females for treatment group in main study.
10 females for control group in main study. - Details on study design:
- PRELIMINARY STUDY
A. Topical application
Irritation assessment following 24h occlusive exposure to test material at 97.4, 50, 30, 10, 5 and 3% (Act.%); skin assessment 3, 24 and 48h after
removal of test substance.
Result: No skin irritation was observed in any concentration tested.
B. Intradermal
0.1 mL of test substance at 10, 5, 3, 1, 0.5, 0.3% (w/w) solution applied intradermally in physiological saline. Assessments was made 24, 48 and 72h post‐administration.
Result: necrosis was observed by 10 and 5% solution. Clear or slight erythema was observed by 3% solution, and this continued up to 72 hr. Slight erythema was observed by 1% solution, but disappeared within 72 hr. No skin reactions were observed by 0.5, 0.3 and 0% solutions.
MAIN STUDY
A. INDUCTION EXPOSURE
Day 0: Treatment group:
− Injection 1: 1:1 mixture (v/v) FCA/physiological saline
− Injection 2: 3% gamma-caprolactone in physiological saline
− Injection 3: 3% gamma-caprolactone in a 1:1 mixture (v/v) FCA/physiological saline
Control group:
- Injection 1: 1:1 mixture (v/v) FCA/physiological saline
- Injection 2: physiological saline
- Injection 3: 1:1 mixture (v/v) FCA/physiological saline
Day 7: Treatment group:
Region, free of fur, was treated topically with a 2 x 4 cm patch of Lint cloth, fully loaded with an undiluted of gamma-caprolactone (Act. 97.4%). Patch was covered by an occlusive bandage and left in place for 48 hours. Due to the non irritant potential of this substance, 10% SLS (Sodium Lauryl Sulfate) in vaseline was topically applied on Day 6 and wiped off on Day 7.
Control group:
Only vehicle (water for injection) was applied.
B. CHALLENGE EXPOSURE
Day 21: Flank of all animals, including controls, treated topically with 0.05 mL of undiluted (97.4%), 50%, 30%, 10%, 5%, 3% (w/w, Act.% in water for injection) test substance for 24h under an occlusive patch.
GRADING SYSTEM
Dermal reactions graded for erythema and edema according to grading scale by Draize:
No erythema: 0
Slight erythema: 1
Clear erythema: 2
Moderate to Severe erythema: 3
Severe erythema with scab: 4
No edema: 0
Slight edema: 1
Clear edema: 2
Moderate edema: 3
Severe edema: 4 - Challenge controls:
- Historical control: 2,4-dinitrochlorobenzene
- Positive control substance(s):
- yes
- Remarks:
- Historical control: 2,4-dinitrochlorobenzene
- Positive control results:
- Sponsor confirmed that the sensitivity and reliability of the experimental technique used by the laboratory is regularly assessed using known sensitizer.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 97.4% to 3% in challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 97.4% to 3% in challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 97.4 to 3% in challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 97.4 to 3% in challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- other: No specific information provided
- Group:
- positive control
- Dose level:
- No specific information provided
- Remarks on result:
- other: No specific information provided
- Interpretation of results:
- not sensitising
- Conclusions:
- The test material, hexan-4-olide, is not classified as skin sensitiser under the test conditions.
- Executive summary:
In a dermal sensitization study (0214-3) with hexan-4-olide (97.4%) in physiological saline, young female Hartley albino guinea pigs were tested in a maximisation test. For induction, 3% hexan-4-olide in physiological saline (intradermal injections) and undiluted hexan-4-olide in physiological saline (topical application) was used. For challenge, 3, 5, 10, 30, 50% and undiluted hexan-4-olide in water was used for topical application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. The positive control was 2,4-dinitrochlorobenzene.
The positive control, 2,4-dinitrochlorobenzene, gave the appropriate response. No positive reactions were evident after the first challenge application at 24 or 48 hours, neither when treated with physiological saline alone nor when treated with 3, 5, 10, 30, 50% and undiluted test article dilutions.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation (in vivo):
There are no in vivo studies available for octan-4-olide. Read-across was performed with a GPMT from hexan-4-olide (CAS No. 695-06-7).
In a dermal sensitization study (equivalent or similar to OECD406/GLP) with hexan-4-olide (97.4%) in physiological saline, young female Hartley albino guinea pigs were tested in a maximisation test. For induction, 3% hexan-4-olide in physiological saline (intradermal injections) and undiluted hexan-4-olide in physiological saline (topical application) was used. For challenge, 3, 5, 10, 30, 50% and undiluted hexan-4-olide in water was used for topical application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. The positive control was 2,4-dinitrochlorobenzene and gave the appropriate response. No positive reactions were evident after the first challenge application at 24 or 48 hours, neither when treated with physiological saline alone nor when treated with 3, 5, 10, 30, 50% and undiluted test article dilutions. The substance was not sensitising. Octan-4-olide is also predicted not to be a dermal sensitizer.
The results from this study are acceptable to use in the human health risk assessment.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information in the dossier, octan-4-olide (CAS No/ 104-50-7) does not need to be classified for skin sensitisation when the criteria
outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied, based on the read-across study from hexan-4-olide (CAS No. 695-06-7).
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