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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study conducted in accordance with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(1981)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Glyoxal pure, solution appx. 40%
- Physical state: colorless liquid
- Analytical purity: about 40% in water
- Lot/batch No.: Tank 409 (12 Sept 1986)
- Stability: stability has been demonstrated by analysis when stored at ca. 8 °C
- Storage condition of test material: cooling

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, Extertal, Germany
- Weight range at study initiation: 250-309 g
- Housing: 5 animals per cage, Makrolon cage type IV
- Diet (e.g. ad libitum): 341.4 mm (Kaninchen-Meerschweinchen-Haltungsdiät), FA. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum, supplemented twice a week with about 2 g of ascorbic acid per 10 litres of water
- Acclimation period: at least 7 days prior test initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): housing in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h/ 12 h

REMARK:
- The feed used in the study was assayed for contaminants. In view of the aim and duration of the study the contaminants occuring in commercial feed did not influence the results.
- The drinking water is regularly assayed for contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF SE. In view of the aim and duration of the study there were no special requirements exceeding the specifications of the drinking water.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
- The concentrations used for testing were selected on the basis of the results of a pretest;
- For the first induction, the test substance was used as 20% solution in either distilled water or Freund´s adjuvant/water (1:1);
- For the second induction, the test substance was used as such, i.e. unchanged;
- For both challenges, the test substance was used as 10% solution in distilled water;
- All test solutions were prepared immediately prior treatment, using an Ultraturrax or a magnetic stirrer for mixing.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
- The concentrations used for testing were selected on the basis of the results of a pretest;
- For the first induction, the test substance was used as 20% solution in either distilled water or Freund´s adjuvant/water (1:1);
- For the second induction, the test substance was used as such, i.e. unchanged;
- For both challenges, the test substance was used as 10% solution in distilled water;
- All test solutions were prepared immediately prior treatment, using an Ultraturrax or a magnetic stirrer for mixing.
No. of animals per dose:
10 animals per control group (2 groups)
20 animals per test group
Details on study design:
- The test method was based on Magnusson and Kligman (J. Invest. Dermatol. 52, 268-276, 1969)
- A test group of 20 and two control groups of respectively 10 Pirbright White, Dunkin, Hartley guinea pigs were used for the adjuvant test procedure; the test concentrations were selected upon the results of a preliminary test.
- The first induction was intradermal, and the test substance was used as 20% solution in distilled water, resp. in Freund´s adjuvant/water (1:1).- The second induction was percutaneous occlusive and the test substance was applied unchanged.
- The two challenges were percutaneous occlusive, and the test substance was used as 10% solution in distilled water; skin readings were performed after 24, 38 and 72 hours following each challenge.
- As recommended by Annex VI/II D of the Council Directive of July 29, 1983 for the 5th Amendment of the Directive 67/548 EEC (= 83/467 EEC), the results were considered to be positive when at least 30% of the experimental animals exhibit skin reactions; furthermore, only the findings obtained 48 hours after application were taken into account for the determination of the sensitization rate.
- Negative controls: the control animals were used to rule out a substance-induced primary skin irritation.
Positive control substance(s):
yes
Remarks:
; dinitrochlorobenzene (DNCB) was tested twice a year as positive control substance on the selected guinea pig strain in the testing laboratory.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% TS in aqua dest.
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
Control group 1: after both challenges, no positive skin reaction was seen. Control group 2: This control group only was considered for rechallenge; no positive skin reaction was seen.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% TS in aqua dest.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Control group 1: after both challenges, no positive skin reaction was seen. Control group 2: This control group only was considered for rechallenge; no positive skin reaction was seen..
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10% TS in aqua dest.
No. with + reactions:
7
Total no. in group:
19
Clinical observations:
One animal in the test group died 7 days after intradermal induction. After the first challenge and at reading time point 48 h, 7/19 animals showed positive skin reactions, consisting mostly of distinct erythema.
Remarks on result:
other: see Remark
Remarks:
Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% TS in aqua dest.. No with. + reactions: 7.0. Total no. in groups: 19.0. Clinical observations: One animal in the test group died 7 days after intradermal induction. After the first challenge and at reading time point 48 h, 7/19 animals showed positive skin reactions, consisting mostly of distinct erythema. .
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
10% TS in aqua dest.
No. with + reactions:
11
Total no. in group:
19
Clinical observations:
After the second challenge, 11/19 animals were scored positive (slight to distinct erythema).
Remarks on result:
other: see Remark
Remarks:
Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 10% TS in aqua dest.. No with. + reactions: 11.0. Total no. in groups: 19.0. Clinical observations: After the second challenge, 11/19 animals were scored positive (slight to distinct erythema)..

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information