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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:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to valid guidelines and was performed under GLP. All necessary parameters have been documented including the sensitivity of the Guinea pig strain
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study carried out prior to REACH regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
TK 10622 (TGIC) , Triglycidyl Isocyanurate.
Purity: commercial grade (> 93%), Batch number 80507178

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
Albino Dunkin Hartley Guinea pigs (HsdPoc: DH, SPF strain)
The male guinea pigs were of 5-7 weeks of age, and weighed 382-502 gm, acclimatization was 1 week, one animal used for intradermal, 2 animals for epidermal pre-tests
Animals kept under standard laboratory conditions such as 15 air changes per hour, 22 +/-3 °C, 40-70% humidity, 12hour light/dark cycle, and individually in Macrolon type-3 cages with soft wood bedding

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Freunds’ adjuvant (FDA) / saline (1:1), corn oil
Concentration / amount:
The optimal concentrations were 5% for intradermal , and 30 %/25% for epidermal applications. (induction)
a concentration of 25% in corn oil was used. (challenge)
Challengeopen allclose all
Route:
epicutaneous, semiocclusive
Vehicle:
other: Freunds’ adjuvant (FDA) / saline (1:1), corn oil
Concentration / amount:
The optimal concentrations were 5% for intradermal , and 30 %/25% for epidermal applications. (induction)
a concentration of 25% in corn oil was used. (challenge)
No. of animals per dose:
10 control & 20 dosed
Details on study design:
The sensitivity of the strain of guinea pigs was regularly tested with α-hexylcinnamaldehyde
TK 10622 (TGIC) was dissolved in corn oil or suspended in FDA/saline (1:1).
Scoring of the skin reactions was performed according to Draize (1959).
In a pre-test the lowest irritating concentration for intradermal and epidermal applications were established in one and 2 male guinea pigs. The optimal concentrations were 5% for intradermal , and 30 %/25% for epidermal applications.
Intradermal application was performed by mixing 5% TGIC in FDA/saline, and intradermal injection. Epidermal application was performed by placing a filter paper soaked with 0.2 ml (2x2 cm) on the shaved skin of the flanks of the animals at a concentration of 30% in corn oil. For challenge applications, a concentration of 25% in corn oil was used.
For the intradermal induction, a 6x8 cm area of the dorsal skin was clipped free of hair, and three pairs of injections were made: FDA/saline mixture, Test article in corn oil (5%), test article in FDA/saline (5%); the control animals received the same injections, but without TGIC.
Epidermal application was performed on day 8, on the previously clipped skin area with a 2x4 cm filter paper soaked with a 30% solution of TGIC in corn oil (0.3 ml), and covered with an elastic bandage for 48 hours. Control animals received the same treatment but without TGIC. Skin reactions were assessed 24 and 48 hours following removal of the dressing.
The first challenge application was performed on day 14 following the first application, and epidermal patches of 2x2 cm of filter paper soaked with TGIC dissolved in corn oil (0.2 ml) was placed on the shaved skin and covered with an elastic bandage for 24 hours. After removal of the bandage, the skin was depilated and scores were made at 24 and 48 hours post removal.
The second challenge application was performed on day 29, using the same procedure as for the first challenge.
Readings of the score were made 24 and 48 hours after removal of challenge patches under fluorescent light.
No statistical analysis was performed on the data

Challenge controls:
Control animals received the same treatment but without TGIC.
Positive control substance(s):
yes
Remarks:
α-hexylcinnamaldehyde.

Results and discussion

Positive control results:
ca. 80 % of the animals were sensitized

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30 % for epidermal challenge.
No. with + reactions:
4
Total no. in group:
20
Clinical observations:
slight erythemas
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 % for epidermal challenge.. No with. + reactions: 4.0. Total no. in groups: 20.0. Clinical observations: slight erythemas .
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
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: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
TGIC was a weak sensitizer under the conditions of the test
Executive summary:

Using the modified Maximisation assay according to OECD guideline 406, TGIC showed only weak skin sensitizing properties in Guinea pigs, as only 25 and 5% of the animals showed weak reaction to first and second challenge inductions