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Diss Factsheets

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:
1986-03-04 to 1986-03-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Nonylphenol
EC Number:
246-672-0
EC Name:
Nonylphenol
Cas Number:
25154-52-3
IUPAC Name:
2-nonylphenol
Details on test material:
- Name of test material (as cited in study report): Nonylphenol
- Substance type: pure active substance
- Physical state: liquid
- Stability under test conditions: not mentioned
- Storage condition of test material: not mentioned
- Other: none

Test animals / tissue source

Species:
rabbit
Strain:
other: Small White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: conventional, singly in stainless steel cages
- Diet (e.g. ad libitum): K4 complete feed for rabbits ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per h): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1986-03-04 To: 1986-03-25

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm³
Duration of treatment / exposure:
72 h
Observation period (in vivo):
1, 24, 48 and 72 h, and 6, 8, 10, 14, 17 and 21 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm physiological saline
- Time after start of exposure: 72 h


SCORING SYSTEM: according to guideline


TOOL USED TO ASSESS SCORE: ophtmalic lamp, fluorescein 72 h after administration

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 h
Score:
38.42
Max. score:
110
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.44
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
not reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
1.67
Max. score:
2
Reversibility:
not reversible
Irritant / corrosive response data:
AVERAGE SCORE
- Cornea: 1.44
- Iris: 1.00
- Conjuntivae (Redness): 3.00
- Conjuntivae (Chemosis): 1.67
Other effects:
The iris were reddened, strong circumcorneale injections were noted. One animal showed a white thread on the pupil and a necrotic spot on the mucosa. All animals had strongly incrusted eye lids and later on hair loss around the eye (due to detaching of the crust).

Any other information on results incl. tables

Table: Irritant/corrosive response data for each animal at each observation time of each animal from the test

Score at time point

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

1 h

1/1/1

 0/0/0

 2/3/3

2/2/1

24 h

1/1/1

 1/1/1

 3/3/3

2/3/2

48 h

2/2/1

 1/1/1

 3/3/3

1/2/2

72 h

1/2/2

 1/1/1

3/3/3

1/1/1
 6 days 2/2/1  1/1/1  3/3/3 2/2/1
 8 days 2/2/2 1/1/1  3/3/2 1/1/0
 10 days 3/3/0 1/1/1  3/3/2 1/1/0
 14 days 4/3/0 1/1/1  3/3/1 0/1/0
 17 days 4/3/0  1/1/0  2/2/1 1/1/0
 21 days 4/3/0  1/1/0  2/2/0 0/1/0

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Risk of serious damage to eyes Criteria used for interpretation of results: EU
Conclusions:
Based on irreversible effects Nonylphenol is corrosive in this study.
Executive summary:

In a primary eye irritation study, 0.1 cm³ of ≥ 98% (w/w) Nonylphenol (undiluted) was instilled into the conjunctival sac of the right eye of 3 female Small White Russian rabbits for 72 h. After exposure the eyes were rinsed with phsyiological saline. Animals were then observed for 21 days. Irritation was scored by the method of OECD 405 guideline.

The irritation index is 38,42/110. Irritation was irreversible. In this study, Nonylphenol is corrosive to the eye.