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EC number: 941-593-4 | CAS number: -
First challenge reading
Test item concentration 2%
Second challenge reading in second group of ten test and 5 control animals:
Rechallenge second group:
Grading challenge reactions:
0. No visible change
1. Discrete or patch erythema
SUMMARY INCIDENCE OF GRADINGS BY ORGAN/GROUP/SEX
Necropsy Status: TERMINAL SACRIFICE GROUP (K0)
Incidence table - Selected findings with grades
No. Animals per Dose Group
SKIN TEST SITE (A) No.Examined
- Hyperplasia epidermal
- Inflammatory cell infiltrate
- Edema dermal
SKIN CONTROL SITE (B) No.Examined
Control animals: Individual findings and grading
SKIN TEST SITE (A)
SKIN CONTROL SITE (B)
Test animals: Individual findings and grading
SKIN CONTROL SITE (B)
Hypersensitivity in the Albino Guinea Pig (Maximization Test) according to OECD guidelines no. 406 (1992) "Skin Sensitization".
The study was based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens" (1970).
Test item concentrations selected for the main study were based on the results of a preliminary study.
In the main study, ten experimental animals were intradermally injected with a 0.2% concentration and epidermally exposed to a 5% concentration. Five control animals were similarly treated, but with vehicle alone (corn oil).
Two weeks after the epidermal application all animals were epidermally challenged with a 2% test item concentration and the vehicle. Since it could not be decided whether the item is a sensitizer or not, additional animals were treated similarly. One week after the first challenge the additional animals were rechallenged using the same procedures.
When the results of the two first challenges are combined this results in a discrete or patchy erythema in 45% of the animals at 24 hours after exposure and which was still observed in 25% of the animals at 48 hours after exposure when compared to the control animals. In the rechallenge similar responses of 50% and 20% were found, at 24 and 48 hours after exposure respectively. No skin reactions other than scaliness were evident in all control animals.
Histopathology of the rechallenge of the additional animals showed epidermal hyperplasia (70%), inflammatory cell infiltrate (100%), and edema (10%) in the experimental animals treated with test item. However, inflammatory cell infiltrate was also found in 30% of the experimental animals challenged with the control substance.
In the control animals 40% showed epidermal hyperplasia and 60% showed inflammatory cell infiltrate. No abnormalities were shown when the control animals were treated with the control substance.
Considering that the skin reactions from the challenge with 2% were also observed in some animals during preliminary irritation testing, that none of the reactions attain a grade which should be regarded as indicative of skin sensitisation, and were already for a large part resolved at the second reading after 48 hours, it is most likely that the observed reactions are associated with irritation and local toxicity rather than an indication to sensistisation.
Also histological examination indicated that reactions in the test animals did not reach levels above what was already observed in control animals.
The results are therefore not considered to indicate potential sensitisation.
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