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EC number: 203-347-8 | CAS number: 105-95-3
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Additional toxicological data

Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1994-12-06 to 1995-01-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD test guideline No. 406 and in compliance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- UK GLP Compliance Program (inspection date: 1994-01-21)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,4-dioxacycloheptadecane-5,17-dione
- EC Number:
- 203-347-8
- EC Name:
- 1,4-dioxacycloheptadecane-5,17-dione
- Cas Number:
- 105-95-3
- Molecular formula:
- C15H26O4
- IUPAC Name:
- 1,4-dioxacycloheptadecane-5,17-dione
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): HR 94/130966
- Physical state: clear colourless slightly viscous liquid
- Storage condition of test material: + 4 °C in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: David Hall Limited, Burton-on-Trent, Staffordshire, UK
- Age at study initiation: 8 to 12 weeks old
- Weight at study initiation: 422-535 g
- Housing: singly or in pairs in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Guinea Pig FD1 Diet ad libitum (Special Diets Services Limited, Witham, Essex, UK)
- Water (e.g. ad libitum): mains tap water ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22 °C
- Humidity (%): 51-65 %
- Air changes (per hr): approximately 15 per hr
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: arachis oil BP for intradermal injection; unchanged for topical induction; 1:1 ethanol / diethylphtalate for topical challenge
- Concentration / amount:
- Intradermal induction: 5 % w/v; Topical induction: undiluted; Topical challenge 50 and 25 % w/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: arachis oil BP for intradermal injection; unchanged for topical induction; 1:1 ethanol / diethylphtalate for topical challenge
- Concentration / amount:
- Intradermal induction: 5 % w/v; Topical induction: undiluted; Topical challenge 50 and 25 % w/v
- No. of animals per dose:
- 20 test and 10 control animals
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal induction: 2 females, 5 or 1 % w/v in arachis oil B.P. 5 % w/v was selected for the main study as the highest concentration that caused only mild to moderate skin irritation and was well tolerated systemically.
- Topical induction: 2 males; 100, 75, 50 and 25 % v/v in 1:1 ethanol diethylphtalate. The highest concentration producing only mild to moderate dermal irritation after a 48-h occlusive exposure was 100 %.
- Topical challenge: 2 males; 100, 75, 50 and 25 % v/v in 1:1 ethanol diethylphtalate. The highest non-irritant concentrations selected for the main study challenge were 50 and 25 % v/v.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 injections (Day 0) + 1 topical application (Day 7)
- Test groups: 1/ 1:1 FCA plus distilled water
2/ 5 % w/v dilution of test material in arachis oil B.P.
3/ 5 % w/v dilution of test material in a 1:1 preparation of FCA plus distilled water
- Control group: 1/ 1:1 FCA plus distilled water
2/ Arachis oil B.P.
3/ 50 % w/v dilution of Arachis oil B.P. in a 1:1 preparation of FCA plus distilled water
- Site: shoulder region
- Concentrations: 5 % w/v for injection; undiluted as supplied for topical application
- Duration: 48 h for topical application
- Evaluation: 24 and 48 h after injections; 1 and 24 h after patch removal
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 21
- Site: right shorn flank
- Concentrations: 50 and 25 % v/v
- Duration: 24 h
- Evaluation (hr after challenge): approximately 24 and 48 h after challenge dressing removal - Challenge controls:
- None
- Positive control substance(s):
- yes
- Remarks:
- Historical control data on 2,4-Dichlorobenzene are included
Study design: in vivo (LLNA)
- Statistics:
- none
Results and discussion
- Positive control results:
- Summary of positive control data from the lab are available. The latest study was conducted between 1994-10-31 and 1994-11-24 with 2,4-Dichlorobenzene. It was administered as a 0.1% concentration in arachis oil BP for the intradermal injections and a 1% concentration in arachis oil BP for the topical induction. Challenge was conducted at concentrations of 0.1% and 0.05% in arachis oil BP. The incidence of sensitisation was 100% (10/10 animals).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % and 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % and 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % and 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % and 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- 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:
- 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.
Any other information on results incl. tables
Skin reactions observed after intradermal induction
Very slight or well-defined erythema was noted at the intradermal induction sites of all test and control group animals at the 24 and 48-h observations.
Skin reactions observed after topical induction
Very slight erythema was noted at the induction sites of three test group animals and well-defined erythema at the induction sites of seventeen test group animals at the one hour observation. Very slight erythema was noted at the induction sites of eighteen test group animals and well-defined erythema persisted at the induction sites of two test group animals at the 24-h observation.
No skin reactions were noted at the treatment sites of the control group animals at the 1- and 24-h observations.
Skin reactions observed after topical challenge
No skin reactions were noted at the challenge sites of the test or control group animals at the 24- and 48-h observations.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- HR 94/130966 did not produce evidence of skin sensitisation during the study.
- Executive summary:
In a dermal sensitisation study performed according to the OECD guideline No. 406 and in compliance with GLP, HR 94/130966 was tested in Hartley guinea-pigs using the Guinea-Pig Maximisation Test method (20 treated animals + 10 controls).
The preliminary study determined the concentration which produced mild to moderate irritation to be used for the intradermal induction (5%) and for the topical induction (100%). 50 and 25 % were selected as the highest non-irritant test substance concentration for the challenge.
HR 94/130966 diluted in Arachis oil B.P. at 5 % (w/w) was administered by injection for intradermal induction. Topical induction was performed with the test material as supplied, 7 days after intradermal injections. For the challenge, HR 94/130966 was tested at 50 and 25 % v/v in a mixture of 1:1 ethanol/diethylphtalate.
The sensitivity of the guinea-pig is checked periodically at Safepharm with known sensitizers, like HCA and Mercaptobenzothiazole.
HR 94/130966 did not produce evidence of skin sensitization during the study.
Under the test conditions, HR 94/130966 is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP) and of the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for skin sensitisation endpoint.
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