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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 406
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test with non-LLNA method was already available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Iodo-tris(triphenylphosphine)copper(I)
EC Number:
454-330-9
EC Name:
Iodo-tris(triphenylphosphine)copper(I)
Cas Number:
15709-82-7
Molecular formula:
Hill formula: C54H45CuIP3 CAS formula: C54H45CuIP3
IUPAC Name:
Iodo-tris(triphenylphosphine)copper(I)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 219001
- Expiration date of the lot/batch: January 01 , 2004

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: dry, room temperature, closed container

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
Species / Strain: Guinea-pig/Dunkin Hartley, Crl:(HA)BR
Sex: male
Supplier: Charles River Wiga GmbH, D-97320 Sulzfeld
Hygiene status upon supply: SPF
Age at start of acclimatisation: approximately 15 days
Acclimatisation: 7 days before administration (main study). In this time no signs were observed which indicate an illness or other injury.
Body weight at start of dosing of the main study: 247.1 g ± 8.3g (n=15)
Identification: ear notches, cage labelling showing the animal number, study number, control or dose group

Study design: in vivo (non-LLNA)

Induction
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 5 % in Arachis oil

b) Topical: 25 % in Petrolatum

Concentration of test material and vehicle used for each challenge:
25 % in Petrolatum
Challenge
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 5 % in Arachis oil

b) Topical: 25 % in Petrolatum

Concentration of test material and vehicle used for each challenge:
25 % in Petrolatum
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Details on study design:
Day 0: Induction by Intracutaneous Injection
Day 6: Preparation of Skin Area for Induction by Epicutaneous Administration
Day 7: Induction by Epicutaneous Administration
Day 20: Preparation of Skin Area for Challenge
Day 21: Challenge by Epicutaneous Administration
Days 23 and 24: Assessment of Challenge Reaction

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
not sensitising
Executive summary:

The skin sensitisation potential of the test item was investigated in the Guinea-Pig Maximisation Test with the Dunkin Hartley albino strain, whose sensitivity to Benzocaine had been demonstrated.

The choice of doses for the main experiment based on the results of the pilot study. The animals showed a very homogeneous reaction to the administration of the test item.

No clinical signs were observed in the course of testing. The body weights and the body weight gain were not affected by the treatment.

The intracutaneous injection of the 5 % (w/v) suspension of the test item in arachis oil induced slight oedema and slight erythema (grade 1). In combination with sensitisation potentiating FCA slight to moderate erythema and oedema were observed.

The pretreatment with 10 % sodium lauryl sulphate in vaseline caused the intended slight to moderate erythema in all animals on day 7.

The epicutaneous administration of the 25 % (w/w) mixture of the test item with vaseline did not cause any irritation.

The challenge with the 25 % (w/v) mixture of the test item with vaseline did not cause any irritation signs in all animals. The skin fold thickness was not affected by the treatment.