Registration Dossier
Registration Dossier
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EC number: 204-428-0 | CAS number: 120-82-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 971
- Report date:
- 1971
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- A series of exposures was given to the male albino guinea-pigs over a three-week intervals; the first five guinea-pigs received nine topical applications of 0.05 mL varying concentrations (50% x 4, 75% x 5) in f.a.d. (13% guinea-pig fat in a 1:1 solution of acetone and dioxane) to clipped abraded skin, and the other five animals received four sacral intradermal injections of 0.1 mL 1% solution v/v of test material in DMP (dimethylphtalate). After a two-week rest period, the test animals were challenged for sensitization by applying 0.05 mL of 75% and 95% (v/v) concentrations to shaved intact shoulder skin. A group of 10 previously unexposed guinea-pigs received similar applications at the time of challenge to provide a direct comparison of the challenge reactions of skin of similar age.
- GLP compliance:
- no
- Type of study:
- not specified
- Justification for non-LLNA method:
- The study pre-dates LLNA method
Test material
- Reference substance name:
- 1,2,4-trichlorobenzene
- EC Number:
- 204-428-0
- EC Name:
- 1,2,4-trichlorobenzene
- Cas Number:
- 120-82-1
- Molecular formula:
- C6H3Cl3
- IUPAC Name:
- 1,2,4-trichlorobenzene
- Test material form:
- not specified
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Remarks:
- Albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: N/A
- Microbiological status of animals, when known: N/A
- Age at study initiation: N/A
- Weight at study initiation: 500 g
- Housing: N/A
- Diet (e.g. ad libitum): N/A
- Water (e.g. ad libitum): N/A
- Acclimation period: N/A
- Indication of any skin lesions: N/A
ENVIRONMENTAL CONDITIONS
- Temperature (°C): N/A
- Humidity (%): N/A
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): N/A
- IN-LIFE DATES: N/A
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- other: epicutaneous, unknown (Group 1)
- Vehicle:
- other: f.a.d
- Concentration / amount:
- 50% x 4, 75% x 5
- Day(s)/duration:
- 9 days
- Adequacy of induction:
- not specified
- Route:
- other: intradermal (Group 2)
- Vehicle:
- other: DMP
- Concentration / amount:
- 1% / 0.1 mL x 4 days
- Day(s)/duration:
- 4 days
- Adequacy of induction:
- not specified
Challengeopen allclose all
- No.:
- #1
- Route:
- other: epicutaneous, unknown (Group 1 + 2)
- Vehicle:
- other: f.a.d.
- Concentration / amount:
- 75% / 0.05 mL
- Day(s)/duration:
- After a two-week rest period
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- other: epicutaneous, unknown (Group 1 + 2)
- Vehicle:
- other: f.a.d.
- Concentration / amount:
- 95% / 0.05 mL
- Day(s)/duration:
- After a two-week rest period
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 5 (Group 1) + 5 (Group 2)
- Details on study design:
- Cf. principles of method if other than guideline
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 95%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: all 10 animals showed irritant reactions
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: all 10 animals showed irritant reactions
Any other information on results incl. tables
Table 7.4.1/1: Reactions on intact Guinea Pig Skin
| Test animals | Control animals | ||
Concentration (% in f.a.d.) | 75% | 95% | 75% | 95% |
Primary irritation test – 24 hrs | 4+, 6 neg. | 4+, 6 neg. | - | - |
Challenge test – 24 hrs | 3+++, 7+++ | 4+++, 6++ | 3+++, 7++ | 3+++, 7++ |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause skin sensitisation but produced irritation.
- Executive summary:
A series of exposures was given to the male albino guinea-pigs over a three-week intervals; the first five guinea-pigs received nine topical applications of 0.05 mL varying concentrations (50% x 4, 75% x 5) in f.a.d. (13% guinea-pig fat in a 1:1 solution of acetone and dioxane) to clipped abraded skin, and the other five animals received four sacral intradermal injections of 0.1 mL 1% solution v/v of test material in DMP (dimethylphtalate). After a two-week rest period, the test animals were challenged for sensitization by applying 0.05 mL of 75% and 95% (v/v) concentrations to shaved intact shoulder skin. A group of 10 previously unexposed guinea-pigs received similar applications at the time of challenge to provide a direct comparison of the challenge reactions of skin of similar age.
The test item did not cause skin sensitisation but produced irritation.
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