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Toxicological information

Skin sensitisation

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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:
1971
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

Constituent 1
Chemical structure
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

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.