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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion) and in accordance with the Principles of GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Principles of method if other than guideline:
not applicable
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-phenoxypropan-2-ol
EC Number:
212-222-7
EC Name:
1-phenoxypropan-2-ol
Cas Number:
770-35-4
Molecular formula:
C9H12O2
IUPAC Name:
1-phenoxypropan-2-ol
Details on test material:
- Name of test material (as cited in study report): DOWANOL PPH
- Physical state: clear colourless to light yellow liquid
- Analytical purity: 94.91%
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: MD270852TZ
- Expiration date of the lot/batch: 25 May 1999
- Stability under test conditions: stable
- Storage condition of test material: At room temperature 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: Broekman Institute , Someren, The Netherlands
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: < 3.5 kg
- Housing: individual housing
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, p e l l e t diameter 4 mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day. In addition, hay (BMI, Helmond, the Netherlands) was provided once a week
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

IN-LIFE DATES: From: 22 June, 1998 To: 3 August, 1998

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml of undiluted test material
Duration of treatment / exposure:
single
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours, 7 and 14 days after instillation of the test substance.
Number of animals or in vitro replicates:
3 male animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: The eyes o f each animal were examined approximately 1, 24, 48 and 72 hours, 7 and 14 days after instillation of the test substance

SCORING SYSTEM: Refer to attachment

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Reversibility:
fully reversible within: 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0.7
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
2.3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
3
Reversibility:
fully reversible within: 14 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Reversibility:
fully reversible within: 14 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
1.3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Instillation of 0.1 ml of DOWANOL PPH into one eye of each of three rabbits resulted in effects on the cornea, iris and conjunctivae. The corneal injur y consisted of opacity (maximum grade 1) and epithelial damage (maximum 75-90% of the corneal area). As a result of the corneal injury , pannus (neovascularisation o f the cornea) was apparent in one animal, 7 days after instillation . The corneal injury had resolved within 7 days in two animals and within 14 days in the third animal. Iridic irritation (grade 1) was observed and had completely resolved within 48 hours in one animal, within 72 hours in the second animal and within 7 days in the third animal.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days in all animals. Reduced elasticity of the eyelids was observed in two animals 72 hours after instillation.
There was no evidence of ocular corrosion and staining of peri-ocular tissues was not observed.
Other effects:
No symptoms o f systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, DOWANOL PPH was classified as irritating to eyes according to EU classification
Executive summary:

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC,B.5, 'Acute Toxicity - Eye irritation' and OECD No.405, 'Acute Eye Irritation/Corrosion'. Single samples of 0.1 ml of DOWANOL PPH were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours, 7 and 14 days after instillation. Instillation of DOWANOL PPH resulted in effects on the cornea, iris and conjunctivae. The corneal injury consisted of opacity (maximum grade 1) and epithelial damage (maximum 75-90% of the corneal area). As a result of the corneal injury, pannus (neovascularisation of the cornea) was apparent in one animal, 7 days after instillation. The corneal injury had resolved within 7 days in two animals and within 14 days in the third animal. Iridic irritation (grade 1) was observed and had completely resolved within 48 hours in one animal, within 72 hours in the second animal and within 7 days in the third animal. The irritation of the conjunctivae consisted of redness, chemosis and discharge and had completely resolved within 14 days in all animals. Reduced elasticity of the eyelids was observed in two animals 72 hours after instillation. Based on these results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), DOWANOL PPH should be labelled as: irritating to eyes (R 36).