Registration Dossier
Registration Dossier
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EC number: 203-916-0 | CAS number: 111-86-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1987
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Unsuitable test system (not suitable to detect weak sensitisers), challenge dose seems too high
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Principles of method if other than guideline:
- Mouse ear swelling test
- GLP compliance:
- not specified
- Type of study:
- mouse ear swelling test
Test material
- Reference substance name:
- Octylamine
- EC Number:
- 203-916-0
- EC Name:
- Octylamine
- Cas Number:
- 111-86-4
- Molecular formula:
- C8H19N
- IUPAC Name:
- octan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): C-1042
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breding Laboratories, Kingston, NY
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 20-22 grams
- Housing: in groups of 2 to 5
- Diet: Purina Laboratory Chow # 5001, ad libitum
- Water: municipal water supply, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 67-76°F
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- Induction: 1.0% v/v
Challenges: 10% v/v
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- Induction: 1.0% v/v
Challenges: 10% v/v
- No. of animals per dose:
- 20
- Details on study design:
- Induction and challenge schedule:
FCA administration: 50% FCA; 20 µL administered to two sides f the abdomen, by intradermal injection
Induction: 1 % active substance open epicutaneous ; 100 µL, on days 1, 2, and 3
Challenge: 10 % active substance open epicutaneous; 10 µL to both the ventral and the dorsal surface of the left ear - Positive control substance(s):
- yes
- Remarks:
- DCNB
Results and discussion
- Positive control results:
- Positive, performed as expected
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% 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: 10% challenge. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- 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: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 8.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 1%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Any other information on results incl. tables
POSITIVE CONTROL:
80 and 100 % of the animals showed a positive response (at least 20 % increase in ear thickness) after 24 and 48 h, respectively.
TEST GROUP:
Few animals challenged with the TS showed weakly positive reactions at challenge or re-challenge in either the test group or
in the irritation control group: The incremental increases in ear thickness ranged from 0 - 10 %.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Octylamine was negative in the MEST. The MEST is, however, not able to identify weak sensitizers. It is therefore concluded that octylamine lacks strong sensitizing properties.
- Executive summary:
N-octylamine was negative in a Mouse Ear Swelling Test (MEST) using two groups of 10 treated mice each. The open epicutaneous induction concentration was 1% octylamin, the challenge concentration was 10%. Negative controls and the positive control animals (1% DCNB) performed as expected.
The mouse-ear swelling test (MEST) serves as a screen to detect potent sensitisers (moderate and strong ones). Weak sensitisers are unlikely to be detected in this test. According to EPA guideline OPPTS 870.2600, a negative result in the MEST does not indicate that the substance is a nonsensitizer, and should be confirmed in an accepted test using guinea pigs and or LLNA if appropriate. The test provided no evidence of a sensitising potential of n-octylamine. Also all other amines tested gave no positive response. The functionality of the test system was demonstrated by using an appropriate positive control substance which was clearly positive. Despite the limited number of animals used and the test restrictions, the result can be weighed in relation to the positive control, the dose used to provoke an effect and the negative result obtained with three structure-related primary amines (cyclohexylamine, hexylamine, isopropylamine). Hence, n-octylamine is not considered to be a potent sensitiser and unlikely to elicit a skin allergic reaction (Hoechst, 1987).
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