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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:
09-01-1991 to 12-02-1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD guideline 404 study, performed to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

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

Test material

Constituent 1
Reference substance name:
2-tert.-butylphenol
IUPAC Name:
2-tert.-butylphenol
Constituent 2
Chemical structure
Reference substance name:
2-tert-butylphenol
EC Number:
201-807-2
EC Name:
2-tert-butylphenol
Cas Number:
88-18-6
Molecular formula:
C10H14O
IUPAC Name:
2-tert-butylphenol
Constituent 3
Reference substance name:
o.-tert.-butylphenol
IUPAC Name:
o.-tert.-butylphenol
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 2-tert.-butylphenol
- Physical state: liquid
- Analytical purity: 99.97%
- Purity test date: 2014-05-07
- Lot/batch No.: 1419
- Expiration date of the lot/batch: 05/2015
- Stability under test conditions: stable
- Storage condition of test material: under N2 in tightly closed container at a cool, well ventilated place
- Colour: clear

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 6-10 weeks
- Weight at study initiation: 2.33 - 2.57 kg
- Housing: individually housed in suspended metal cages
- Diet (ad libitum): Spillers Rabbit Diet, Dalgety Agriculture Ltd., Almondsbury, Bristol
- Mains drinking Water (ad libitum):
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 45 - 61%.
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours darkness

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 ml neat liquid applied under a 2.5 x 2.5 cm gauze semiocclusive dressing.
Duration of treatment / exposure:
4 hours or
3 mins
Observation period:
Approximately one hour following removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary
irritation and scored according to the Draize method.
Number of animals:
n=3 rabbits (4 hour exposure)
n=3 rabbits (3 minutes exposure)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

- Type of wrap if used: gauze patch secured in position with a strip of surgical adhesive tape (BLENOERM: approximate size 2.5 cm x 4.0 cm), the trunk of each
rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Time point:
other: 4 hours
Remarks on result:
other: Erythema could not be scored due to corrosive burns on the site of application
Irritation parameter:
erythema score
Time point:
other: 3 minutes
Remarks on result:
other: The material was corrosive
Irritant / corrosive response data:
4-Hour Exposure Period
Severe erythema, haemorrhage of the dermal capillaries and oedema were noted at all treated skin sites one hour after patch removal. Evaluation
of the erythema and oedema was not possible at the 24, 48, 72-hour and 7 day observations due to the presence of other adverse dermal
reactions. These were blanching, hardened dark brown/blackcoloured or undulating scabs and dried blood. Well-defined erythema
surrounded the scabs, with erythema extending up to 8cm beyond the sites of application during the study. These reactions were considered
to be indicative of corrosion.

3 minutes exposure:
Well-defined or moderate to severe erythema was noted at all treated skin sites one and 24-hours after patch removal and at two treated skin sites at the 48-hour observation. Well-defined erythema continued to be noted at one treated skin site at the 72-hour observation.
Moderate to severe oedema was noted at all treated skin sites one and 24 hours after patch removal. Moderate oedema was noted at
two treatment sites at the 48-hour observation. Slight oedema was noted at one treatment site at the 72-hour observation. The reaction
extended up to 5 cm beyond the treatment sites of all animals during the study.
Evaluation of the erythema and oedema was not possible at one treatment site at the 48-hour observation, at two treatment sites at the
72-hour observation and at all treatment sites at the 7-day observation due to other adverse brown/black-coloured scabs,
dermis, thickening of the surrounding the scabs, crust reactions. These included hardened dark light brown discolouration of the episkin,
moderate or well-defined erythema formation, hardened light brown-coloured scabs, reduced regrowth of fur, desquamation, glossy skin and small
superficial scattered scabs.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive)
Conclusions:
o-tert butyl phenol is corrosive when applied as a neat liquid to the clipped dorsal skin of New Zealand white rabbits, for 4 hours or 3 mins.
Executive summary:

In an OECD guideline study, o-tert butyl phenol is corrosive when applied as 0.5ml of a neat liquid to the clipped dorsal skin of New Zealand white rabbits (area 2.5 x 2.5cm), for both 4 hours or 3 minutes.