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Diss Factsheets

Administrative data

Description of key information

In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was found to be non-sensitising to the skin (Dreist/ Bayer, 1992).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Dichlorotoluene isomers was investigated in male guinea pigs according to the maximization test tested by Magnusson and Kligman for skin sensitizing properties.
The examination was carried out with the following test item concentrations:
Intradermal induction: 5%
Topical induction: 100%
Provocation: 50% and 25%
The test item was formulated in polyethylene glycol 400
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The GPMT test was conducted in 1992 - at this time point no valid guideline for a LLNA was available
Species:
guinea pig
Strain:
other: BOR:DHPW
Sex:
male
Route:
intradermal
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
Intradermal induction: 5%,
Topic induction: 100%,
Challenge: 50% and 25%
Route:
other: epicutaneous, Fermoflex-Plaster (not defined if occlusive or not)
Vehicle:
other: polyethylene glycol 400
Concentration / amount:
Intradermal induction: 5%,
Topic induction: 100%,
Challenge: 50% and 25%
No. of animals per dose:
20 (test substance group); 10(control group).
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
15
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 15.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
8
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Group:
positive control
Remarks on result:
other: see 'Overall remarks, attachments'.
Remarks:
The sensitivity and reliability of studies according Magnusson and Kligman conducted in the testing facility performing the study with dichloromethylbenzene (Institute of Toxicology at the BAYER AG) were evaluated regularly as required by the test guideline. For the respective time period a separate report (Dreist M, BAYER Report n° 21251) is available. This report is available in German language: Dreist, M.: Ueberpruefung der im Fachbereich Toxikologie der BAYER AG angewandten Methodik des Maximierungstests nach Magnusson und Kligman am Meerschweinchenstamm DHPW unter Verwendung von alpha-Hexylzimtaldehyd BAYER-report Nr. 21251 from 1992-04-03.

Numbers of animals exhibiting skin redness (48 and 72 hours after initiation of challange):

            test substance group (20 animals)           First control group (10 animals)
      Test substance patch     Control patch     Test substance patch     Control patch
 Hours  48  72  48  72  48  72  48 72 
 Challenge                       
 50%  15  0  0  0  8  0  0 0
 25%  0  0  0  0  0  0  0  0

After the first challenge with the 50% test item formulation, 75% of the animals treated with the test item and 80% of the control animals revealed a skin redness. With a 25% formulation of the test item, neither the animals treated with the test item nor the control animals were positive.

The skin reactions found after application of the 50% test item are due to a primary irritating potential of the test item concentration.

Under the conditions of the assay, no evidence of a skin sensitization potential was found for dichlorotoluene isomers.

Interpretation of results:
GHS criteria not met
Executive summary:

In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was tested in male guinea pigs. The testing was performed with following test substance-concentrations:

Intradermal induction: 5%

Topic induction: 100%

Challenge: 50% and 25%

Polyethylene glycol 400 served as vehicle.

After the first challenge with a 50% test item formulation, 75% of the animals treated with the test item and 80% of the control animals revealed a skin redness. With a 25% formulation of the test item, neither the animals treated with the test item nor the control animals were positive.

The skin reactions found after application of the 50% test item are due to a primary irritating potential of the test item concentration.

The substance is therefore not-sensitising to the skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was tested in male guinea pigs. The testing was performed with following test substance-concentrations:

Intradermal induction: 5%

Topic induction: 100%

Challenge: 50% and 25%

Polyethylene glycol 400 served as vehicle.

After the first provocation with 50% test substance formulation, 75% of the test substance animals and 80% of the control animals showed skin reddening. With 25% test substance formulation neither the test substance animals nor the control animals showed any reactions. The skin reddening after a treatment with the 50% formulation can be evaluated as a primary skin irritating potential of the test substance. No references for a skin sensitising potential can be found. The substance therefore is non-sensitising to the skin (Dreist/ Bayer, 1992).

The sensitivity and reliability of studies according Magnusson and Kligman conducted in the testing facility performing the study with dichloromethylbenzene (Institute of Toxicology at the BAYER AG) were evaluated regularly as required by the test guideline. For the respective time period a separate report (Dreist M, BAYER Report n° 21251) is available. This report is available in German language:

Dreist, M.: Ueberpruefung der im Fachbereich Toxikologie der BAYER AG angewandten Methodik des Maximierungstests nach Magnusson und Kligman am Meerschweinchenstamm DHPW unter Verwendung von alpha-Hexylzimtaldehyd

BAYER-report Nr. 21251 from 1992-04-03.

For the evaluation of the sensitivity and reliability of the test system a complete study (GPMT) according OECD 406 was conducted with alpha-hexyl cinnamaldehyde. Twenty male GP were treated with alpha-hexyl cinnamaldehyde and 20 animals served as control. For the assay the following test item concentrations were used: Intradermal induction: 5%, topical induction: 25% and for challenge: 12% and 3%. Polyethyleneglycol 400 was used as solvent.

After the challenge with 12% alpha-hexyl cinnamaldehyde, 95% of the animals showed a partly slight to moderate skin reddening, and 20% of the control animals showed a partly slight reddening. With a 3% solution of the positive control substance, 20% of the animals revealed partly a slight reddening of the skin, whereas in the control group no skin effects were observed.

Alpha-hexyl cinnamaldehyde reveled under the conditions of the assay a clear skin sensitizing potential. The sensitivity and reliability of the test system is therefore demonstrated.

The GPMT with dichlorotoluene isomere mixture (Dreist M , report n° 21470) was conducted in the time period 1992-03-10 to 1992-04-03 and the sensitivity and reliability test (Dreist M, report n° 21251) for the used GPMT was conducted in the time period 1992-02-18 to 1992-03-13. Therefore the reliability according to OECD GL 406 for a period of 6 months is confirmed.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No data.

Justification for classification or non-classification

In an OECD guideline 406 skin sensitsation study according to Magnusson and Klingman the test substance was found to be non-sensitising to the skin (Dreist/ Bayer, 1992).

According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification for skin sensitisation is not justified.