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Diss Factsheets

Administrative data

Description of key information

Conclusions for dermal and ocular irritation based on OECD Guideline studies, performed under GLP for the read-across substance 3-hydroxy-2-naphthoic acid (3-HNA).

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
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
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.
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

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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989-09-13 - 1983-10-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented study, performed to OECD Guideline, performed under GLP.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG breeding colony,
- Weight at study initiation: 2.7 - 3.9 kg
- Housing: singla cage
- Diet (e.g. ad libitum): rabbit diet Altromin 2123, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, ad libitum
- Acclimation period:

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/-2
- Humidity (%): 55 +/-10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
other: PEG 400
Controls:
other: untrreated eye regarded as control
Amount / concentration applied:
100 mg test substance mixed with 0.1 mL PEG 400
Duration of treatment / exposure:
24 hours. Thereafter the eyes were rinsed with physiological saline (37°C)
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
3
Details on study design:
Eyes were evaluated at: 1, 24, 48 and 72 hours and on days 7 and 14 after application. Grades attained at 24, 48 and 72 hours after application were included in the mean gradings of ocular lesions.
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: Mean of 24, 48, 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24,48, 72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) were observed at any time
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
All findings covered by the scoring system were fully reversible within the observation period of 14 days.

Additional response date:

Discharge: from 1 to 72 h post application, fully reversible within 7 days
Nicitating membrane: partial gray discoloration, fully reversible within 14 days
Cornea surface: uneven, not reversible within the observation period of 14 days
Corneal vascularization: starting at day 7, advanced at day 14, not reversible within the observation period of 14 days
Other effects:
no other effects reported
Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information REGULATION (EC) No 1272/2008 Criteria used for interpretation of results: EU
Conclusions:
In view of the corneal lesions still evident at the end of the observation period (14 days) and considered to be irreversible the test substance was considered to pose a risk of serious damage to eyes.
Executive summary:
According to the classification criteria of the EC Directive,with particular attention to the time during the trial where corneal damage is not reversible, the substance BONS TTR is described as irritating to the eye. There is the"danger of serious damage to eyes".

3-Hydroxy-2-naphthoic acid was tested for eye irritation according to OECD Guideline 405 and in compliance with GLP. Each of three New Zealand White rabbits was treated by administration of a single dose of 100 mg test substance mixed with polyethylene glycol 400 (0.1 ml) to the conjunctival sac of one eye. Eyes were evaluated for ocular lesions at 1, 24, 48 and 72 hours and on days 7 and 14 after application. At 1 hour after application, swelling and conjunctival injection as well as secretion (clear, tinted by the test substance) were observed in all animals. At 24, 48 and 72 hours, conjunctivitis and diffuse corneal opacities were found. One animal showed iritis at 24 and another at 48 hours. At 7 and 14 days after the application,unevencorneal surface and/or corneal vascularization were seen in all animals. In view of the corneal lesions still evident by 14 days post application and considered to be irreversible the test substance was considered to pose a risk of serious damage to eyes.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation classification based on criteria established in REGULATION (EC) No 1272/2008. For the eye irritation endpoint, the actual irritation values would only place the substance in Category 2 ("irritating to eyes"). However, other effects which were not reversible within 21 days (Cornea surface: uneven, not reversible within the observation period of 14 days; Corneal vascularization: starting at day 7, advanced at day 14, not reversible within the observation period of 14 days) placed the substance in Category 1 ( "irreversible effects on the eye").


Justification for selection of skin irritation / corrosion endpoint:
Based on the criteria established in REGULATION (EC) No 1272/2008, the read-across substance 3-hydroxy-2-naphthoic acid would be considered not irritating.

Justification for selection of eye irritation endpoint:
Classic irritation, as defined by OECD

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the results of studies from the read-across substance, the substance of record, 6 -hydroxy-naphthoic acid (6 -HNA) would not be classified as a skin irritant, but would be classifed as a Category 1 eye irritant. These designations are based on criteria set forth in

REGULATION (EC) No 1272/2008.