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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-11-18 to 2009-01-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to OECD guideline under GLP

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
dated 24th April, 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
of Council regulation No. 440/2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
4-hydroxybenzoic acid
EC Number:
202-804-9
EC Name:
4-hydroxybenzoic acid
Cas Number:
99-96-7
Molecular formula:
C7H6O3
IUPAC Name:
4-hydroxybenzoic acid
Details on test material:
Name of test material: p-Hydroxybenzoesäure
CAS No.: 99-96-7
Sponsors Batch No.: 08/1000/10,1-20
production date: 20.10.2008
purity: 99,94%
colour: white
form: powder
storage: protected from light and moisture at room temperature
expiry date: October 2011

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
-three female rabbits, 12-13 weeks old, weight during the test: 2.54-2.94 kg
-the animals were kept for a minimum of five days for an acclimatisation period
-each animal was kept in an individual box at 17-23 °C, lighting was 12h continuous light and 12 h continuous dark,
relative hunidity ranged from 30-70%
-animals had free access to drinking water and food
-rate of air exchange: ca. 15 changes / hour
-light/ dark ratio: 12 h/ 12 h
-weight of animals: (beforetest /after test):
animal 1: (2,69 kg/2,77kg)
animal 2: (2,54 kg/2,60kg)
animal 3: (2,79 kg/2,94kg)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: moistened patch with water
Controls:
not required
Amount / concentration applied:
0,5 g test substance (as supplied) was applied on the skin with a water moistened patch ca. 6 cm².
The patch was fixed with surgical tape.
Duration of treatment / exposure:
The exposure remained for 4 hours on one shaved flank of the animal, the other flank served as control, without treatment.
After that the treated area was rinsed with distilled water.
Observation period:
1 hour, 24, 48, 72 hours after removal of the patch
Number of animals:
3 female
Details on study design:
one animal was tested first, then two other animals were tested
one flank of the animal was tested, the other flank served as control

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
and eschar score
Basis:
animal #1
Time point:
other: 1h
Score:
>= 1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
erythema score
Remarks:
and eschar score
Basis:
animal #1
Time point:
other: 24h, 48h, 72h
Score:
>= 0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
and eschar score
Basis:
animal #2
Time point:
other: 1h, 24h, 48h, 72h
Score:
>= 0
Max. score:
0
Irritation parameter:
erythema score
Remarks:
and eschar score
Basis:
animal #3
Time point:
other: 1h, 24h, 48h, 72h
Score:
>= 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1h, 24h, 48h, 72h
Score:
>= 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1h, 24h, 48h, 72h
Score:
>= 0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1h, 24h, 48h, 72h
Score:
>= 0
Max. score:
0
Irritant / corrosive response data:
Only one animal showed a very slight erythema after one hour, which was fully reversibel after 24h.
All other results on erythema, eschar and edema in all animals were at the score rate: zero
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
according to EU classification, the item does not have to be classified
according to GHS classification, the item does not have to be classified
Executive summary:

 0,5 g 5-HBA were applied to 6 cm² skin of three female New-Zealand White rabbits as test animals. Exposure was 4 hours with observations at 1, 24, 48, 72 hours post exposure. The study is valid and classified as reliable without restrictions.


The results showed short term mild irritation in one animal. The limits for classification were not surpassed. Concluding, p-Hydroxybenzoic acid does not have to be classified as skin irritant according to CLP classification criteria.