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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The purity of the test substance was known: 99.4%. The authors argued that the in vivo data were generated in studies carried out since 1981 according to OECD Test Guideline 404 and following the principles of Good Laboratory Practice.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988
Reference Type:
publication
Title:
Skin irritation: reference chemicals data bank
Author:
Bagley D.M., Gardner J.R., Holland G., Lewis R.W., Regnier J.F., Stringer D.A., Walker A.P.
Year:
1996
Bibliographic source:
Toxicology in Vitro, 10, 1-6.
Reference Type:
publication
Title:
Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes
Author:
Draize J.H., Woodard G., Calvery H.O
Year:
1944
Bibliographic source:
Journal of Pharmacology, 82, 377-390.
Reference Type:
publication
Title:
Skin irritation and corrosion: reference chemicals data bank.
Author:
ECETOC
Year:
1995
Bibliographic source:
Technical Report N°66, 208. European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The heating equipment failed during the acclimatisation period, resulting in the low temperatures recorded. Temperature was typically greater than 14°C.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Guaiacol was purchase from Givaudan-Roure and its purity was 99.4%.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS:
- Source: from Gorseside Rabbits, Northchurch, Berkhamsted, Herfordshire, and delivered by road transport
- Age at study initiation: 10-12 weeks
- Weight at study initiation: approximatively 2 kg
- Housing: individually in grid bottomed metal cages
- Diet: ad libitum, a commercially available antibiotic free rabbit diet (SQC standard rabbit pellets produced by special Diets Services, Witham, Essex)
- Water: ad libitum, mains drinking water via automatic nozzles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS:
- Temperature (°C): 17-23°C
- Humidity (%): 37-68%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 h light/ 12h dark

IN-LIFE DATES: from 8th november to 15th november 1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
Amount applied: 0.5 ml, undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days
Number of animals:
4
Details on study design:
TEST SITE:
- Area of exposure: over a 2.5 cm square (approximately 6 square cm)
- % coverage: no data
- Type of wrap if used: "Elastoplast" elastic adhesive bandage 10 cm wide.

REMOVAL OF TEST SUBSTANCE:
- Washing: The treated site was cleansed by gentle swabbing with cotton wool soaked in warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: The treated area was scored for erythema and oedema using a numerical system based on that described by Draize et al. (1944) and the primary dermal irritation index (PDII) was calculated.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.8
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
2.38
Other effects:
none

Any other information on results incl. tables

Remark: 

The primary irritation index (PII = PDII) = ((SUM erythema  24/48/72 hr)+ (SUM oedema 24/48/72 hr)) / (3 x Number of animals). Since no scale was 

identified in the OECD protocol, the AFNOR scale was used to interpret the results as following: PDII below 0.5, non-irritant; 0.5-3,  slightly irritant; 

3-5, moderately irritant; 5.8, severely irritant.
The numerical scores obtained were summed and a mean was calculated. When the mean value obtained for either erythema or oedema equalled 

or exceeded 2, the test substance was considered as irritant.
The scores were determmined from the numerical values given to the irritation observed at the 24, 48 and 72 hour. The corresponding PDII was  

2.38 and guaiacol was determined as "slightly irritant".

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
- Interpretation of results: slightly irritating
- Criteria used for interpretation of results: other: EU GHS

Classification: not irritating
Executive summary:

In a dermal irritation study (Haynes for RIFM, 1988), four New-Zealand White female rabbits were dermally exposed to 0.5 ml of guaiacol for 4 hours to left flank (6 cm square).  Test sites were covered with a semi-occlusive dressing for 4 hours. Animals then were observed for 7 days.  Irritation was scored by the method of Draize.
In this study, guaiacol is slightly irritating to the skin.

However, guaiacol is officialy classified as Irritant for skin (Xi R38), in the Regulation (EC) n° 1272/2008 annex VI table 3.2 and as Skin Irrit. Category 2 (H315: Causes skin irritation) according to the Regulation (EC) n° 1272/2008 annex VI table 3.1.