Registration Dossier
Registration Dossier
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EC number: 203-915-5 | CAS number: 111-85-3
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
Test material
- Reference substance name:
- 1-chlorooctane
- EC Number:
- 203-915-5
- EC Name:
- 1-chlorooctane
- Cas Number:
- 111-85-3
- Molecular formula:
- C8H17Cl
- IUPAC Name:
- 1-chlorooctane
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan-Winkelmann, Versuchstierzucht, Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: 471 +/- 31 g
- Housing: 5 animals per cage (Makrolon cage type IV)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 25.04.1993 To: 11.06.1993
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25.0% in corn oil (w/w)
Due to its low water solubility n-octyl chloride can not be applied using water as vehicle. However, n-octlyl chloride can be easily mixed with oil. In a pre-study 2.5, 25 and 50% n-octyl chloride were tested. A solution of 25% n-octyl chloride in corn oil was found to be the highest non-irritation concentration following repeated dosing and was therefore used in the main study.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- 25.0% in corn oil (w/w)
Due to its low water solubility n-octyl chloride can not be applied using water as vehicle. However, n-octlyl chloride can be easily mixed with oil. In a pre-study 2.5, 25 and 50% n-octyl chloride were tested. A solution of 25% n-octyl chloride in corn oil was found to be the highest non-irritation concentration following repeated dosing and was therefore used in the main study.
- No. of animals per dose:
- 20 test animals
10 control animals - Details on study design:
- RANGE FINDING TESTS:
- Number of animals: 4
- Exposure period: 6h
- Concentrations: 2.5, 25.0 and 50.0% test item in corn oil (w/w), 100% test item
- Observations: 6h, 24h, 48h and 7d post application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6h
- Test groups: 1
- Control group: 1
- Site: left flank
- Frequency of applications: 7 days
- Concentration: 25% in corn oil (w/w)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 6h
- Test groups: 1
- Control group: 1
- Site: right flank
- Concentration: 25% in corn oil (w/w)
- Evaluation (hr after challenge): 6, 24, 48 and 72h
OTHER: - Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzol
Results and discussion
- Positive control results:
- 0.1% 1-Chloro-2,4-dinitrobenzol in vaseline
50% of the 10 test animals show a positive skin reaction after 72h.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 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: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 % (at challenge, inductions with vehicle)
- 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: 25 % (at challenge, inductions with vehicle). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 % (at challenge, inductions with vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % (at challenge, inductions with vehicle). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 % (at challenge, inductions with vehicle)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25 % (at challenge, inductions with vehicle). No with. + reactions: 0.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Using the method of Buehler under the conditions of the study no skin sensitization potential of the test item was observed.
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