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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
in vivo study in the rabbit. The existing in vivo data is considered to fulfil the in vitro eye irritation requirement.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-January-12 to 1998-February-2
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Examinations were not made on days 7 and 14 after application as outlined by the guideline. Alternatively examinations were conducted on days 6, 8, 10, 13, and 17. This deviation did not negatively affect the validity of the test.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(α,α-dimethylbenzyl)phenol
EC Number:
209-968-0
EC Name:
4-(α,α-dimethylbenzyl)phenol
Cas Number:
599-64-4
Molecular formula:
C15H16O
IUPAC Name:
4-(α,α-dimethylbenzyl)phenol
Details on test material:
- Name of test material: p-Cumylphenol
- Substance type: organic
- Physical state: solid white flakes
- Analytical purity: 99%
- Impurities: <1% phenol, <1% o-Cumylphenol, <1% 2,4-di-Cumylphenol
- Storage condition of test material: under protective gas in a humidity-free environment

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH
- Weight at study initiation: 2.4 to 2.5 kg
- Housing: individually in cages
- Diet: fed K4 Alleindiaet for rabbits, Ssniff Special Feed GmbH (4770 Soest), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 60 ±5 %
- Air changes: 15/hour
- Photoperiod: 12 hours of light/12 hours of darkness

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount: The eyelid was lifted and 0.1 g of the test substance was applied to the conjunctival sac of the right eye. (The left eye was treated in one animal.)

Duration of treatment / exposure:
72 hours
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after the application.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: Seventy-two hours after the application the treated eyes were rinsed with a sodium fluorescein solution to examine corneal damage and were rinsed with a warm physiological saline (sodium chloride) solution.
- Time after start of exposure: 72

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: eye lamp and fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
41.1
Max. score:
110
Reversibility:
not reversible
Remarks on result:
other: The effects of the test substance on the eye increased over the 21 day observation period, particularly in the cornea.

Any other information on results incl. tables

Individual Irritation Scores

Corneal Assessment

 

1 hour

24 hour

48 hours

72 hours

6 days

8 days

10 days

13 days

17 days

21 days

 

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

A,B

AxBx5

Animal 1

1,4

20

1,4

20

1,4

20

1,4

20

2,3

30

2,3

30

2,3

30

2,3

30

2,3

30

2,3

30

Animal 2

1,4

20

2,4

40

2,3

30

2,3

30

2,3

30

2,3

30

2,3

30

2,3

30

2,3

30

3,3

45

Animal 3

1,4

20

1,4

20

2,4

40

2,4

40

2,4

40

2,4

40

2,4

40

2,4

40

2,4

40

3,4

60

 Mean

 

20.00

 

26.67

 

30.00

 

30.00

 

33.33

 

33.33

 

33.33

 

33.33

 

33.33

 

45.00

A Opacity
B Area of opacity

Iris Assessment

 

1 hour

24 hour

48 hours

72 hours

6 days

8 days

10 days

13 days

17 days

21 days

 

A

Ax5

A

Ax5

A

Ax5

A

Ax5

A

Ax5

A

Ax5

A

Ax5

A

Ax5

A

Ax5

A

Ax5

Animal 1

0

0

1*

5

0

0

0

0

c1

5

c1

5

stc1

5

stc1

5

stc1

5

stc1

5

Animal 2

0

0

1*

5

1*

5

1*

5

xc1

5

c1

5

stc1

5

stc1

5

stc1

5

stc1

5

Animal 3

0

0

1*

5

1*

5

1*

5

xc1

5

c1

 

stc1

5

stc1

5

stc1

5

 

5

 Mean

 

0.00

 

5.00

 

3.33

 

3.33

 

5.00

 

5.00

 

5.00

 

5.00

 

5.00

 

5.00

A Iris Score
* Reddened
x Partially reddened
c Circumcorneal injection: enlargement of the ciliary and conjunctival blood vessels near the margin of the cornea with reduction in size peripherally
st Strong

Conjunctiva Assessment

 

1 hour

24 hour

48 hours

72 hours

6 days

8 days

10 days

13 days

17 days

21 days

 

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

A,B,C

A+B+Cx2

Animal 1

2,1,2

10

3,2,2

14

!3,1,2

12

!3,1,2

12

2,1,0

6

2,1,0

6

2,1,0

6

2,1,0

6

2,1,0

6

2,1,0

6

Animal 2

2,1,2

10

3,2,2

14

!3,2,2

14

!3,1,2

12

#3,1,0

8

3,1,2

12

2,1,0

6

2,1,0

10

2,1,2

10

2,1,0

6

Animal 3

2,1,2

10

3,2,2

14

!3,1,2

12

!3,1,2

12

#3,1,0

8

3,1,1

10

2,1,0

6

2,1,1

6

2,1,0

6

2,1,0

6

 Mean

 

10.00

 

14.00

 

12.67

 

12.00

 

7.33

 

9.33

 

6.00

 

7.33

 

7.33

 

6.00

A Redness
B Chemois
C Discharge
! White secretions (pus)
# Mucous membrane partially bloody

 

The average of the maximum values for all experimental animals is reported as X(bar) The average for all assessment time points was corresponded to the irritation index, which was compared to the following classification scheme:

0-10 not irritating

11-25 slightly irritating

26-56 moderately irritating

57-110 severely irritating

Per Annex VI of 79/831/EEC, the average scores for cornea, iris and conjunctivae at 24, 48 and 72 hour were determined.

Results according to Annex VI:

Cornea: X(bar) = 1.56

Iris: X(bar) = 0.78

Conjunctiva:

Redness: X(bar) = 3.00

Chemosis: X(bar) = 1.44

Applicant's summary and conclusion

Interpretation of results:
other: Category 1 (irreversible effects on the eye) in accordance with EU criteria
Conclusions:
Under the conditions of this study, PCP is considered to cause irreversible effects to the eye of Russian rabbits.
Executive summary:

The eye irritation potential was investigated in a study performed per OECD Test Guideline 405 under GLP conditions

Three Russian rabbits were dosed with 0.1 g of the neat test substance and the eyes were examined at 1, 24, 48 and 72 hours and 6, 8, 10, 13, 17 and 21 days after the application.

Under the conditions of this study, PCP is considered to cause irreversible effects to the eye. The effects of the test substance on the eye increased over the 21 day observation period, particularly in the cornea.