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EC number: 253-575-7
CAS number: 37640-57-6
PRELIMINARY IRRITATION STUDY
Based on the results, the test substance concentrations selected for the
main study were a 5% concentration for the intradermal induction and a
20% concentration for the epidermal induction exposure (Table 1).
Table 1: Skin reactions after intradermal injection
24 hours after injection
48 hours after injection
*: a 20% test substance concentration was considered the highest concentration that could be prepared homogeneously to a visible acceptable level. Note: white/yellow staining was observed at all epidermally treated skin sites, 24 and 48 hours after exposure
No signs of irritation were observed to the highest test substance
concentration epidermally tested. Therefore, the test site of all
animals was treated with 10% SDS approximately 24 hours before the
epidermal induction in the main study, to provoke a mild inflammatory
Table 2: Skin reactions after epidermal exposure
1) Induction phase (Table 3)
The reactions noted in the experimental and control animals after the
epidermal induction exposure were considered to be enhanced by the SDS
Table 3: Induction readings
Intradermal injection (Day 3; erythema grade)
Epidermal exposure (Day 10)
A: 1:1 Mixture of FCA and water for injection; B: A 5% test substance concentration (Experimental); vehicle (Control); C: 1:1 Mixture of FCA and a 10% concentration (Experimental) or vehicle (Control); D: A 20% test substance concentration (Experimental); vehicle (Control); (a) Small scabs; Note: White/Yellow staining by the test substance was observed at all epidermally test substance treated skin sites.
2) Challenge phase
No skin reactions were evident after the challenge exposure in the
experimental and control animals (see Table 4). White/yellow staining
was observed at the test substance treated skin sites, 24 and 48 hours
after challenge. This staining did not hamper the scoring of the skin
Table 4: Challenge
*: test substance concentration; #: corn oil
Table 5: Skin reactions in the challenge phase (Number of animals with
0% (Vehicle; 24/48*)
Experimental group (10 females)
Conrol group (5 females
*: time (hours) after the challenge exposure.
3) Toxicity / Mortality
No mortality occurred and no symptoms of systemic toxicity were observed
in the animals of the main study.
3) Body Weights
Body weights and body weight gain of experimental animals remained in
the same range as controls over the study period (see Table 6).
Table 6: Mean body weight (g)
Group / Sex (Treatment)
Mean body weight ± standard deviation (g) at indicated time period
Group 1 / Females (Control)
316 ± 21
432 ± 25
Group 2 / Females (Experimental)
313 ± 26
438 ± 33
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