Registration Dossier
Registration Dossier
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EC number: 200-860-9 | CAS number: 75-31-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Oct./Nov. 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- No LLNA test has been performed as a reliable non-LLNA skin sensitising assay has already been available.
Test material
- Reference substance name:
- Isopropylamine
- EC Number:
- 200-860-9
- EC Name:
- Isopropylamine
- Cas Number:
- 75-31-0
- Molecular formula:
- C3H9N
- IUPAC Name:
- propan-2-amine
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Monoisopropylamine
- molecular formula: C3H9N
- molecular weight: 59.09
- Substance type: organic
- Physical state: liquid
- Analytical purity: 99.7 %
- Purity test date:
- Lot/batch No.: 9301P0355
-Origin: Elf Atochem
- Storage condition of test material: room temperature, protected from light
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Centre dÉlevage Lebeau, France
- Age at study initiation: no data
- Weight at study initiation: 432 +-34 g (m); 440 +-22 g) (f)
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: >=5 d before start
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-1
- Humidity (%): 50 +-20
- Air changes (per hr): no technically forced exchange
- Photoperiod (hrs dark / hrs light): 12 / 12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.1 mL of a 0.1 % dilution in aqueous isotonic saline on day 1 of study
epicutaneous induction: 0.5 mL of 1 % dilution in aqueous isotonic saline on day 8 of study
10 % = maximum non-irritant concentration (epicutaneous challenge)
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 mL of the Maximum Non Irritant Concentration (10 %) on day 22 of study
- No. of animals per dose:
- 5 m + 5 f (pos. and neg. control groups); 10 m + 10 f (test group)
- Details on study design:
- RANGE FINDING TESTS:
Minimum Irritant Concentration for id and epicutaneous application
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2x (day 1 and 8)
- Exposure period: 48 h (dermal) following 24h treatment with 0.5 mL 10% laurylsulphate
- Test groups: FCA/saline, FCA + 0.1% TS/saline, 0.1% TS/saline (intradermal); 0.5 mL 1% TS/saline (dermal)
- Control group: FCA/saline, FCA/saline + saline, saline (intradermal); 0.5 mL saline (dermal)
- Site: scapular region
- Frequency of applications: 1x (id), 1x (dermal)
- Duration: 8 d
- Concentrations: 0.1 % (id), 1 % (dermal)
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (dermal)
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test groups:
- Control group:
- Site: right flank (TS) / left flank (saline)
- Concentrations: 10 %
- Evaluation (hr after challenge): 24 and 48 h
C. OTHER
Clinical observation,
body-weight control until day 25
Necropsy on day 25 - Positive control substance(s):
- yes
- Remarks:
- dinitro 2,4-chlorobenzene
Results and discussion
- Positive control results:
- Challenge with 0.1 % DNCB: erythema scores 2 for 4/5 animals, score 1 for 1/5 animals (reading 24 h p.a.)
Challenge with 0.5 % DNCB: erythema scores 4 for 2/5 animals, score 3 for 3/5 animals (reading 24 h p.a.)
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- 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: 20.0. Clinical observations: none.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- 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: 10.0. Clinical observations: none.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- 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: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Group:
- positive control
- Dose level:
- 0.5 % dinitro 2.4 chlorobenzene
- Total no. in group:
- 5
- Clinical observations:
- positive skin sensitization reactions in 100% of the guinea-pigs
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Pre-Test
intradermal: 0.1 % were irritant, 1 % necrotic after 24 h post-application
dermal: 10 % not irritant after 24 h post-application, 25 % were necrotic.
Main test
No clinical signs, no mortalities, normal body-weight gain.
After induction, irritation in the control group and necrosis in treated group were observed.
No cutaneous reaction (scores 0) was observed at 24 and 48 h after dermal challenge at the maximum mon-irritant concentration.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test substance was not sensitising
- Executive summary:
A guinea pig maximisation test was performed according to OECD guideline 406 with 5 animals per sex in the control group and 10 per sex in the treatment group. Intradermal induction was performed on day 1 of study with 0.1 mL of 0.1 % dilution of the test substance in the vehicle isotonic saline. On day 8, epicutaneous induction was done with 0.5 mL of 1 % test substance dilution. Challenge occured at day 22 of study with 0.5 mL of a 10 % test substance in vehicle for 24 h. Cutaneous reactions were scored 24 and 48 h after the end of this treatment. No clinical signs or deaths were observed, and no cutaneous reactions occured.
The positive control DNCB showed positive results in this test system.
Under the conditions of this study, the test substance was considered to be non-senstising.
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