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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:
1989

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

Constituent 1
Chemical structure
Reference substance name:
1,5-naphthylenediamine
EC Number:
218-817-8
EC Name:
1,5-naphthylenediamine
Cas Number:
2243-62-1
Molecular formula:
C10H10N2
IUPAC Name:
1,5-naphthylenediamine
Details on test material:
IUCLID4 Test substance: other TS: purity 98.4 %

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: DHPW
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Cremophor (EL 2%)
Concentration / amount:
Intradermal induction: 2,5%
Topical induction: 50%
1. Provocation: 50%
2. Provocation: 5% and 25%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Cremophor (EL 2%)
Concentration / amount:
Intradermal induction: 2,5%
Topical induction: 50%
1. Provocation: 50%
2. Provocation: 5% and 25%
No. of animals per dose:
20- Test substance groups
10- Control groups
Details on study design:
The animals in the 3 groups were treated as follows:
a) Test substance group:
1. cranial pair of intradermal injections: Freud´s complete adjuvant (Difco Lab.) 1:1 with sterile physiological saline.
2. medial pair of intradermal injections: 1,5-Naphthylendiamin 2,5% in Cremophor EL (2% v/v) in sterile, physiological NaCl-solution.
3. caudal pair of intradermal injections: 1,5-Naphthylendiamin 2,5% in Cremophor EL (2% v/v) in sterile, physiological NaCl-solution and Freud´s
complete adjuvant (half and half).
b) Control groups
The animals of the control groups were treated the same way as the test substance groups, however no test substance was added to the medial
and caudal pairs of intradermal injections.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
Slight to medium reddening
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: Slight to medium reddening.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
10
Total no. in group:
20
Clinical observations:
Slight to medium reddening
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 20.0. Clinical observations: Slight to medium reddening.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
Slight to medium reddening
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: Slight to medium reddening.

Any other information on results incl. tables

No. of animals with sensitized skin after 48 hours after provocation:

   Test substance group (20 animals)  1., respectively 2. control group (10 animals respectively)
  Test substance patch   Control patch   Test substance patch  Control patch 
 1.Provocation 50%  9  0  0
 2.Provocation 25%  10  0 0
  5%  4  0  0

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
Classification: sensitizing
Executive summary:

Male guinea pigs were tested with the Maximisation test (MAGNUSSON and KLINGMAN).

The test was executed with following concentrations of the test substance:

Intradermal Induction: 2,5%

Topical Induction: 50%

1. Provokation: 50%

2. Provokation: 5% and 25 %

The test substance was formulated with Cremophor EL (2% v/v) in sterile, physiological NaCl-solution.

After the 1. provocation in 9 of 20 animals an obvious skin sensitization was observed with 50% test substance-formulation.

After the 2. provocation with the 25% test substance-formulation in 10 animals and with the 5% test substance-formulation in 4 animals a skin sensitization was observed.

The test substance was found to be sensitizing to the skin.