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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 16 February 1987 to 27 May 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a recognised guideline and under GLP conditions. However, the purity of the test substance is not specified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: Hybrid Albino New-Zealand
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hybrid Albino New-Zealand
- Sex: males
- Sources: *Charles River: Saint Aubin Les Elbeuf - 76410 Cléon - France
*E.G.A.V: Saint Mars d'Egrenne - 61350 Passais La Conception - France
*E.S.D: Roman - 01400 Châtillon sur Chalaronne - France
- Age at study initiation: no data
- Weight at study initiation: 2.5 +/- 0.2 kg
- Housing: individual housing, in polystyrene cages, of internal dimensions 560x355x315 mm, with a perforated floor
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/- 3°C
- Humidity: 30 to 70%
- Air changes: no data
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 3 March 1987 To: 17 March 1987

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Concentration: 0.5 mL undiluted
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: a surface of about 6 cm2
- % coverage: no data
- Type of wrap: a Codex hydrophilic eight layer gauze pad


REMOVAL OF TEST SUBSTANCE
- Washing: the bandages were removed and if necessary excess test substance which had not penetrated was wiped away with a gauze pad moistened with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM: based on erythema and oedema formation, according to directive OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: aspect of burn on all the zone of application
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.34
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: see table of results
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

Erythema:

 animal

mean 24/48/72 hours 

 n°1 4.00 
 n°2 4.00
 n°3 4.00
 n°4 4.00
 n°5 4.00
 n°6 4.00
mean  4.00

After 14 days: mean = 4.00 for all animals + presence of eschars on all the zone of application

Oedema:

 animal

mean 24/48/72 hours 

 n°1 3.67 
 n°2 2.67
 n°3 3.67
 n°4 3.67
 n°5 3.00
 n°6 3.33
mean  3.34

After 14 days: mean = 0.00 for all animals

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
4-tert-butylpyrocatechol 85% in water is classified as :
- Skin corrosive category 1B according to UN/EU GHS classification criteria
Executive summary:

In a dermal irritation study (Hazleton, 1987), hybrid albino New-Zealand White rabbits (6 males) were dermally exposed to 0.5 mL of 4 -tert-butylpyrocatechol 85% in water on a 6 cm2 body surface area. Test sites were covered with a semi-occlusive dressing for 4 hours. Animals were then observed for 14 days. Irritation was scored by the method of directive OECD 404.

After 1 hour of exposure, severe erythema and moderate (1/6 rabbits) or severe (5/6 rabbits) oedema were observed in all treated animals. Severe erythema was not reversible after 14 days and oedema was fully reversible within 14 days. In this study, 4 -tert-butylpyrocatechol 85% in water was corrosive to the skin based on the observed skin reactions.