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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP defined.

Data source

Reference
Reference Type:
publication
Title:
Skin Sensitization by 1,4-Dichlorbenzene in the Guinea Pig Maximization Test
Author:
Bornatowicz N, Winker N, Maruna H
Year:
1995
Bibliographic source:
Dermatosen 43, 16-21, 1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
contnet: 99%

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 460 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5
- Humidity (%): 55
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/ 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: peanut oil, vaseline, 1,2-propylene glycol. 95 % Ethanol
Concentration / amount:
INTRADERMALE INDUKTION
--Test substance: 0.1 % P-dichlorobenzene in peanut oil.
control group: peanut oil
--positve substance(2,4-Dichloronitrobenzene): 0.02 % in 1,2-propylene glycol
control group: propylene glycol
EPIKUTANE INDUKTION
--test substance :25 % p-dichlorobenzene in vaseline
control group: vaseline
--positive substance (2,4 dichloronitrobenzene)0.05 % in 95% Ethanol
control group: 95 % ethanol
EPIKUTANE CHALLENGE
--testsubstance and control group 25 % p-dichlorobenzene in vaseline
--positive substance and control group 0.05 2,4-dinitrochlorobenzene in 95 % ethanol
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: peanut oil, vaseline, 1,2-propylene glycol. 95 % Ethanol
Concentration / amount:
INTRADERMALE INDUKTION
--Test substance: 0.1 % P-dichlorobenzene in peanut oil.
control group: peanut oil
--positve substance(2,4-Dichloronitrobenzene): 0.02 % in 1,2-propylene glycol
control group: propylene glycol
EPIKUTANE INDUKTION
--test substance :25 % p-dichlorobenzene in vaseline
control group: vaseline
--positive substance (2,4 dichloronitrobenzene)0.05 % in 95% Ethanol
control group: 95 % ethanol
EPIKUTANE CHALLENGE
--testsubstance and control group 25 % p-dichlorobenzene in vaseline
--positive substance and control group 0.05 2,4-dinitrochlorobenzene in 95 % ethanol
No. of animals per dose:
24 female guinea pigs: test subjects.
24 female guinea pigs: negative control group.
10 female guinea pigs: positive control group (2,4-dinitroclorobenzene).
10 female guinea pigs: control group
10 female guinea pigs: negative control group (2,4-chlorodinitrobenzene).
Details on study design:
experimental day 0: intradermal induction
experimental day 7: epidermal induction
experimental day 21 epidermal challenge
experimental day 23: evaluation of the skin in test animals and control animals
Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene

Results and discussion

Positive control results:
24 hours post application of the challenge 9/10 animals treated with 2,4 dinitrochlorobenzene showed positive reactions
48 hours post application of the challenge 10/10 animals treated with 2,4-dinitrochlorobenzene showed marked reactions.
In the respective control group no skin reaction was observed

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: reading
Hours after challenge:
48
Group:
test group
Dose level:
25 % in vaseline
No. with + reactions:
5
Total no. in group:
24
Clinical observations:
no mortality, reduction of mean bodyweight when compared to the respective control
Remarks on result:
other: see Remark
Remarks:
Reading: other: reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in vaseline. No with. + reactions: 5.0. Total no. in groups: 24.0. Clinical observations: no mortality, reduction of mean bodyweight when compared to the respective control .
Reading:
other: reading
Hours after challenge:
48
Group:
test group
Dose level:
25 % in vaseline
No. with + reactions:
4
Total no. in group:
5
Clinical observations:
evaluated as sensitized (16.4 %)
Remarks on result:
other: Reading: other: reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in vaseline. No with. + reactions: 4.0. Total no. in groups: 5.0. Clinical observations: evaluated as sensitized (16.4 %).
Reading:
other: reading
Hours after challenge:
24
Group:
negative control
Dose level:
vasiline only
No. with + reactions:
3
Total no. in group:
24
Clinical observations:
slight redness of the skin in control animals was evaluated as unspecific reaction
Remarks on result:
other: see Remark
Remarks:
Reading: other: reading. . Hours after challenge: 24.0. Group: negative control. Dose level: vasiline only. No with. + reactions: 3.0. Total no. in groups: 24.0. Clinical observations: slight redness of the skin in control animals was evaluated as unspecific reaction.
Reading:
other: reading
Hours after challenge:
48
Group:
negative control
Dose level:
vaseline only
No. with + reactions:
1
Total no. in group:
24
Clinical observations:
evaluated as sensized animal
Remarks on result:
other: Reading: other: reading. . Hours after challenge: 48.0. Group: negative control. Dose level: vaseline only. No with. + reactions: 1.0. Total no. in groups: 24.0. Clinical observations: evaluated as sensized animal.

Any other information on results incl. tables

A Magnusson and Klingman test on guinea pigs (EEC method, 24 controls, 24 test animals, at induction concentrations of 0.1% intradermally and 25% topically and at challenge concentrations of 25% in petrolatum, positive controls used) demonstrates a rather weak potential for sensitization. At 0.1% intradermally in pre-test, slight irritation was observed in animals. The maximum non-irritating concentration was greater than 25% after topical application because at 25% in petrolatum, no irritation was observed in a pre-test; Sodium Lauryl Sulfate was not applied. Five of the 24 animals in the 1,4-paradichlorobenzene group had positive skin reactions after the challenge exposure. As a positive skin reaction was also detected in one of 24 animals in the negative control group, a total of four of 24 animals in the test group was regarded as sensitized (16,7%). According to the scheme of Magnusson and Klingman the sensitizing potential of 1,4-dichlorobenzene is therefore rated as mild.. No histological examination was conducted (Bornatowicz 1995).

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Executive summary:

According to OECD TG 406 the Guinea Pig Maximization Test according to Magnusson and Klingman was carried out to reveal a possible sensitizing potential of Paradichlorobenzene. Five of the 24 animals in the Paradichlorobenzene-group had positive skin reactions after the challenge exposure. As a positive skin reaction was also detected in one of 24 animals in the negative control group, a total of four of 24 animals in the test group was regarded as sensitized, i.e., 16,7%.

According to the gading and evaluating system given by Magnusson and Klingman the sensitizing potential of Paradichlorobenzene is therefore rated to be mild. The concurrent positive control substance induced clear reaction in all animals.