Registration Dossier
Registration Dossier
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EC number: 210-248-3 | CAS number: 611-06-3
Skin sensitisation
Administrative data
- 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:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
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
Test material
- Reference substance name:
- 1,3-dichloro-4-nitrobenzene
- EC Number:
- 210-248-3
- EC Name:
- 1,3-dichloro-4-nitrobenzene
- Cas Number:
- 611-06-3
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 1,3-dichloro-4-nitrobenzene
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4; purity: 98%.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freud´s Adjuvant, sterile saline, vaseline, paraffin
- Concentration / amount:
see: Any other Information on materials and methods
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Freud´s Adjuvant, sterile saline, vaseline, paraffin
- Concentration / amount:
see: Any other Information on materials and methods
- No. of animals per dose:
- 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- control
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: control. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- erythema scores 1-3; edema scores 1-2
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema scores 1-3; edema scores 1-2.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- control
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- no
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: control. No with. + reactions: 0.0. Total no. in groups: 0.0. Clinical observations: no.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- erythema scores: 1-3; edema scores: 0-2;
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 20.0. Total no. in groups: 20.0. Clinical observations: erythema scores: 1-3; edema scores: 0-2; .
Any other information on results incl. tables
SO-Freetext: Hoechst AG Frankfurt 80
Hoechst AG Frankfurt/Main
RM-Freetext:
24 bis 48 h nach der Ausloesebehandlung konnten bei allen
Tieren kaum wahrnehmbare bis mittelschwere Erytheme und
sehr leichte Oedeme beobachtet werden, die Haut war
teilweise trocken und sproede.
Applicant's summary and conclusion
- Executive summary:
In a sensitisation test (Maximization test) in female Pirbright-White-guinea pigs the treatment was executed as follows:
The intradermal induction treatment took place with 5 % test substance in Paraffin viscous DAB; the dermal induction treatment and the dermal challenge treatment with 25 % test substance in Vaseline white DAB.
Slight to medium-severe erythema and very slight to slight edema could be observed after 24 to 48 hours after bandage removal.
Additionally the skin was dry and rough. The animals of the control group showed no signs of irritation.
The test substance was found to be sensitizing according to EG-directive 83/467/EWG.
Therefore the substance was classified as R 43.
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