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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1983-09-13 - 1983-09-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study, performed to OECD Guideline, performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

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

Test material

Constituent 1
Reference substance name:
3-hydroxy-2-naphthoic acid
EC Number:
202-180-8
EC Name:
3-hydroxy-2-naphthoic acid
Cas Number:
92-70-6
IUPAC Name:
3-hydroxy-2-naphthoic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): BONS TTR
- Molecular formula (if other than submission substance): HOC10H6CO2H
- Molecular weight (if other than submission substance): 188.18
- Physical state: Solid
- Analytical purity: Not given
- Impurities (identity and concentrations): 1% beta-naphthol
- Composition of test material, percentage of components:
- Purity test date: Not given
- Lot/batch No.: 1297/83
- Expiration date of the lot/batch: Not given
- Radiochemical purity (if radiolabelling): Not applicable
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not given
- Storage condition of test material: Stored at 22 degrees C in the dark.
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG breeding colony
- Weight at study initiation: 2,2 - 2,6 kg
- Housing: single cages
- Diet (e.g. ad libitum): Rabbit diet Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: PEG 400
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/patch suspended in 0.32 ml PEG 400
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
Animals were exposed to test article for 4 hours.
Observation period:
Primary observation at 30-60 minutes after removal of patch, with subsequent observations at 24, 48 and 72 hours post patch-removal.
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm patch
- % coverage: Not given
- Type of wrap if used: Cellulose acetate patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not performed.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Scored according to Draize. A test substance is considered to be a skin irritant if it causes an inflammation of the skin, the exposure time up to 4 hours to 24 hours or longer lasting, and corresponds to the following values: mean erythema score or edema score above 2.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1, 2, 3 each
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal: 1, 2, 3 each
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h
Irritant / corrosive response data:
erythema and edema recorded.
Other effects:
No other effects were reported

Any other information on results incl. tables

Average Values for Erythema and Eschar

 Animal 1 0.3 
 Animal 2 0.3 
 Animal 3 0.3 
 Average for all Animals 0.3

Average values for Edema

 Animal 1  0.3
 Animal 2  0.3
 Animal 3  0.3
 Average for all Animals  0.3

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
not irritating under the test conditions.

The mean Draize scores for erythema and edema derived from 24, 48 and 72 hour post treatment observation time points were 0.3 in each of three rabbits. All erythema and edema findings were completely reversible within 48 hours post patch removal. Based on these findings the test substance was considered "not irritant".
Executive summary:
According to the classification criteria of the REGULATION (EC) No 1272/2008EC, and taking into account all relevant toxicological findings, the substance BONS TTR can be described as a not irritating.