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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP complant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK Department of Health, 4 March 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TAEE, tert-amyl ethyl ether, CAS No. 919-94-8
- Lot/batch No.: 00931302
- Description: colourless liquid
- Purity: 99.4%
- Date received: 26 September 2008

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan laboratories UK Ltd, Bicester, UK
- Age at study initiation: 12-20 wk
- Weight at study initiation: 2.55 - 2.72 kg
- Housing: individually housed
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights on 0600-1800 hr)


IN-LIFE DATES: From: 06 May 2009 To: 07 May 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml (neat)
Duration of treatment / exposure:
4 hr
Observation period:
14 d
Number of animals:
2
Details on study design:
Skin on the dorsal/flank was clipped free of hair on the day before treatment. On the day of treatment 0.5 ml neat test substance applied to an area of clipped skin, covered with 2.5 cm x 2.5 cm piece of gauze secured with surgical tape and the trunk of animal wrapped with elasticated corset for the duration of the exposure. The wrappings were removed after 4 hr and test site wiped with cotton wool moistened with distilled water. The treatment site was examined for local reactions 24, 48 and 72 hr after patch removal and any dermal responses recorded using Draize criteria.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Remarks on result:
other: No response present
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hr, 48 hr and 72 hr
Score:
2
Max. score:
2
Remarks on result:
other: Erythema present in both animals to 72 hr. Crust formation at 7 days; slight desquamation at 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr
Score:
0
Max. score:
0
Remarks on result:
other: No response present
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hr
Score:
2
Max. score:
2
Remarks on result:
other: Oedema present in both animals.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hr and 72 hr
Score:
1
Max. score:
1
Remarks on result:
other: Oedema present in both animals to 72 hr, resolved by day 7

Any other information on results incl. tables

Only 2 animals used given irritant response obtained.

No evidence of skin corrosion.

Body weight gains appeared normal.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Irritating to skin
Executive summary:

Skin irritation potential was evaluated in a GLP-compliant guideline study (method B4 of directive 2004/73/EC) using 2 male New Zealand White rabbits. The test sample (0.5 ml) was applied undiluted to an area of clipped dorsal skin (approx. 2.5cm x 2.5 cm) and covered with a semi-occlusive dressing for 4 hr. The wrappings were then removed, the test skin wiped clean with cotton wool moistened with distilled water and skin reactions recorded (Draize criteria) at 1, 24, 48 and 72 hr after patch removal. Well defined erythema (grade 2) and slight or very slight oedema (initially grade 2, decreasing to grade 1) were present from 24 hr to 72 hr at the test site, followed by crust formation at day 7 and slight desquamation at day 14. No corrosive effects were noted. The test substance was irritating to rabbit skin under the conditions of the study.