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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From January 09, 1996 to February 09, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Product number: 06 FHFR555
- pH value: Approximately 5 (10 g/L)
- Appearence: Light yellowish scales
- Melting point: 60-70⁰C
- Solubility: >10 g/L in water, ethanol, isopropanol
- Batch no.: 1061969521
- Storage conditions: Darkness at room temperature in a fume cup-board
-Active ingredient 79.8%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae 88400, Biberach
- Age at study initiation: About 3-5 month
- Weight at study initiation: 2.7-3.8 kg
- Housing: In fully air-conditioned rooms in seperate cages arranged in a battery
- Diet: Ssniff K-H (V2333), ad libitum and hay (approximately 15g daily)
- Water: Automatic water dispensers, ad libitum
- Acclimation period: 1 wk under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 20%
- Photoperiod: 12h light/12h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
0.5g of the test substance pasted with 0.3 mL isotonic saline
Duration of treatment / exposure:
4 hours as well as 3 minutes
Observation period:
Examination of the skin took place after 30-60 minutes as well as 24, 48 and 72 hours after removal of the patches. If the irritation persists 72 hours after removal of the patch (treatment 4h), additional reading were performed after 7, 14 and 22 days.
Number of animals:
1 (treatment 4 hours) and 3 (treatment 3 minutes).
Details on study design:
The substance was applied over the whole surface of a 2.5x2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. After the exposure, all remnants of the test substance were carefully removed from the skin with warm tap water.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 22d
Remarks on result:
other: the mean value have been calculated using the Day 1, 2 and 3 values
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14d
Remarks on result:
other: the mean have been calculated using the Day 1, 2 and 3 values
Irritant / corrosive response data:
Treatment 4 hours: 30-60 minutes upto 22 days after removal of the plaster the animal showed a very slight to well defined erythema. One day up to 7 days after application a very slight oedema was noted. During the observation period, the treated skin area was sporadically dry, rough, indurated, encrusted, chapped and discoloured large beige. 22 days after application pink coloured new skin and a scar was noted.
Treatment 3 minutes: No sigh of irritation was observed during the whole observation period.

Applicant's summary and conclusion

Conclusions:
Under the study conditions, the test substance was found to be corrosive to rabbit skin.
Executive summary:

A study was conducted to determine the skin irritation / corrosion of the test substance according to OECD Guideline 404 and EU Method B.4, in compliance with GLP. A paste containing 0.5 g of the test substance (purity of 79.8%) with 0.3 mL isotonic saline was applied under semi-occlusive patches to the clipped dorsal area of four rabbits. One animal was exposed for 4 h and three animals were exposed for 3 min. The test sites were examined for evidence of primary irritation and scored according to Draize method. No signs of irritation were observed during the whole observation period after exposure to 3 min. However, a 4 h exposure resulted in slight to well defined erythema and a slight oedema, visible 30-60 min up to 22 days after removal of the plaster. Between one and seven days after application, slight oedema was noted. During the observation period, the treated skin area was sporadically dry, rough, indurated, encrusted, chapped and discoloured. Twenty-two days after application, pink coloured new skin and a scar was noted.Under the study conditions, the test substance was found to be corrosive to rabbit skin (Kreiling, 1996).