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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:
1993-06-22 to 1993-07-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study from 1993 readily available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
69.32 % solution of a 98.55 % pure solid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White (Bor:DHPW)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH, Borchen, GERMANY
- Age at study initiation: 9 wk
- Weight at study initiation: 466-521 g (males); 382-471 g (females)
- Housing: 1/Macrolon cage type IV
- Diet: standared diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0-20.5
- Humidity (%): 50-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h/12 h

IN-LIFE DATES: From: 1993-06-22 To: 1993-07-16

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: 0.9% physiological saline
Concentration / amount:
Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: 0.9% physiological saline
Concentration / amount:
Induction 0.5 % intracutaneous
Induction 100 % occlusive epicutaneous
Challenge 30 % occlusive epicutaneous
No. of animals per dose:
10 treatment; 5 vehicle control
Details on study design:
(NB: TS is 69% aqueous solution)

RANGE FINDING TESTS: preliminary test conducted - no details given

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal-3 paired injections; topical)
- Exposure period: topical 48h
- Test group: 10
- Control group: +ve no details on group size; -ve (vehicle) 5
- Site: two rows of 3 sites, one row either side of dorsal mid-line
- Frequency of applications: intradermal treatment day 0; topical induction day 7
- Duration: induction period continues to day 21
- Concentrations:
intradermal: 1:1 FCA saline; 0.5% TS in saline; 0.5% TS 1:1 FCA
topical: 100% TS

B. CHALLENGE EXPOSURE
- No. of exposures: 1 (at two sites: TS and vehicle)
- Day(s) of challenge: day 22
- Exposure period: 24 h
- Test group: 10
- Control group: +ve no details on group size; -ve (vehicle) 5
- Site: flank
- Concentrations: 30% TS in saline
- Evaluation (hr after challenge): 24 and 48 h following patch removal
Challenge controls:
vehicle control
positive control
Positive control substance(s):
yes

Results and discussion

Positive control results:
1,4-phenylenediamine X2 HCl. Last examination April 1993. (No further details given)

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30% TS in saline (NB: TS is 69% in aqueous solution)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% TS in saline (NB: TS is 69% in aqueous solution). No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30% in saline
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% in saline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
1st reading
Group:
positive control
Remarks on result:
other: not specified
Reading:
2nd reading
Group:
positive control
Remarks on result:
other: not specified
Reading:
1st reading
Group:
negative control
Remarks on result:
other: not specified
Reading:
2nd reading
Group:
negative control
Remarks on result:
other: not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A well conducted, well reported guinea-pig skin sensitization test (Magnusson & Kligman method) found in the test substance (a 69% aqueous solution of CHPTAC) no evidence of sensitizing potential when challenged with a 30% solution of the TS in saline. Appropriate negative and positive controls were conducted.
Executive summary:

In a dermal sensitization study (OECD 406) with CHPTAC (69% aqueous solution), young adult female guinea-pigs of the Dunkin-Hartley strain were tested using the method of Magnusson and Kligman. No dermal reactions were seen when challenging with a 30% solution of the test material in saline. In this study, CHPTAC (69%) is not a dermal sensitizer.