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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
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study generated according to internationally accepted testing guidelines and according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Guideline:
other: EC Directive No. 96/54/EEC, B.6, 30 July 1996.
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study performed well before REACH. As a study for skin sensitisation existed no new LLNA test was started.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TDCP
- Physical state: colourless viscous liquid
- Date Received: 10 July 2001
- CAS number: 13674-87-8
- Storage condition of test material: room temperature
- 98.5 % purity

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Saint-Aubin-les-Elbeuf, France.
- Age at study initiation: 1 - 3 months
- Weight at study initiation: 363 + / - 15 g (males) and 353 + / - 10 g (females)
- Housing: Housed individually in polycarbonate cages with stainless steel lid (48 x 27 x 20cm) equipped with a polypropylene bottle.
- Diet: ad libitum, 106 pelleted diet
- Water: ad libitum, FG millipore membrane filtered water
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 + / - 2 degrees C
- Humidity (%): 30 - 70%
- Air changes (per hr): 12 cycles / hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
PRELIMINARY TEST
25% , 10% and 5% (w/w) TDCP in corn oli was administered for the intradermal injection, topical application is neat at 100%.

MAIN TEST
- On day 1, six injections were made deep into the dermis of a 4 x 2 cm clipped interscapular area, using a meedle mounted on a 1 ml plastic syringe. In the anterior section FCA at 50% (v/v) in 0.9% NaCl, in the middle section the test substance at 25% (w/w) in corn oil and in the posterior section test substance at 25% (w/w) in the mixture FCA/0.9% NaCl (50/50). The same injections, without the test substance were made in control animals.
- The animals were treated on day 7 with 0.5ml of sodium lauryl sulphate at a concentration of 10% (w/w) in vaseline, in order to induce local irritation.
- On day 8, a pad of filter paper was fully loaded with the undiluted test substance and was then applied to the interscapular region of the animals in the treated group. The animals of the control group received an applictaion of the vehicle alone under the same experimental conditions. The pad was held in place for 48 hours by means of an adhesive hypoallergenic dressing and an adhesive anallergenic waterproof plaster.
- On day 22, the animals of treated and control groups received an application of the test substance and vehicle. The filter paper of a chamber (Finn chamber) was fully loaded with the undiluted test substance and was then applied to a clipped area of the skin of the posterior right flank of all animals. The vehicle was applied under the same experimental conditions to the skin of the posterior left flank. The chambers were held in place for 24 hours by means of an adhesive anallergenic waterproof plaster.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
PRELIMINARY TEST
25% , 10% and 5% (w/w) TDCP in corn oli was administered for the intradermal injection, topical application is neat at 100%.

MAIN TEST
- On day 1, six injections were made deep into the dermis of a 4 x 2 cm clipped interscapular area, using a meedle mounted on a 1 ml plastic syringe. In the anterior section FCA at 50% (v/v) in 0.9% NaCl, in the middle section the test substance at 25% (w/w) in corn oil and in the posterior section test substance at 25% (w/w) in the mixture FCA/0.9% NaCl (50/50). The same injections, without the test substance were made in control animals.
- The animals were treated on day 7 with 0.5ml of sodium lauryl sulphate at a concentration of 10% (w/w) in vaseline, in order to induce local irritation.
- On day 8, a pad of filter paper was fully loaded with the undiluted test substance and was then applied to the interscapular region of the animals in the treated group. The animals of the control group received an applictaion of the vehicle alone under the same experimental conditions. The pad was held in place for 48 hours by means of an adhesive hypoallergenic dressing and an adhesive anallergenic waterproof plaster.
- On day 22, the animals of treated and control groups received an application of the test substance and vehicle. The filter paper of a chamber (Finn chamber) was fully loaded with the undiluted test substance and was then applied to a clipped area of the skin of the posterior right flank of all animals. The vehicle was applied under the same experimental conditions to the skin of the posterior left flank. The chambers were held in place for 24 hours by means of an adhesive anallergenic waterproof plaster.
No. of animals per dose:
PRELIMINARY STUDY:
one male and one female.

MAIN STUDY
20 test animals (ten male and ten female) and 10 control animals (five male and five female).
Details on study design:
see 'concentration'
Challenge controls:
Control animals were administed vehicle only.
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
100% TDCP challenge
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No signs of erythema or oedema
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 100% TDCP challenge. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No signs of erythema or oedema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Evidence from a study in guinea pigs indicates that TDCP does not possess significant skin sensitisation potential. No information is available on the respiratory sensitisation potential of TDCP.
Under the experimental conditions and according to the maximization method of Magnusson and Kligman, the test substance TDCP does not inudce delayed contact hypersensitivity in guinea pigs.