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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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 405 (Acute Eye 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
- Substance type: yellowish powder
- Physical state:solid
- Impurities (identity and concentrations): ca 1% ß-Naphtol
- Lot/batch No.: 1297/83
- Storage condition of test material: at 22°C in the dark

Test animals / tissue source

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

Test system

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.

Results and discussion

In vivo

Resultsopen allclose all
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

Applicant's summary and conclusion

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.