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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:
March - April 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP OECD 405 guideline-compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
EC Number:
915-333-5
IUPAC Name:
Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
Specific details on test material used for the study:
Of note, in the absence of specific data on the registered Reaction mass of o-(1-phenylethyl) phenol and bis(1-phenylethyl) phenol and 2,4,6-tris(1-phenylethyl)phenol and the obligation to generate some data for intermediates, data from the Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol have been included in the dossier by default as comparable hazard profile could be expected between both substances.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli S.n.c., Via Milano 61, 28341 Arona (Novara) Italy
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 2.5 to 2.8 kg
- Housing: in 62 x 47.5 x 38 cm metal cages with stainless steel feeders
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Yes (exact duration not specified)


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50 +/- 15
- Air changes (per hr): approximately 20/hour
- Photoperiod (hrs dark / hrs light): 12 / 12 (7 a.m. / 7 p.m.)


IN-LIFE DATES: From: March 11, 1997 To: March 14, 1997

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): Not applicable


VEHICLE
Not applicable
Duration of treatment / exposure:
Single instillation in the conjunctival sac of the right eye (lids gently held together for 3 to 4 seconds)
Observation period (in vivo):
1, 24, 48 and 78 hours after instillation
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: sterile saline
- Time after start of exposure: 24 hours


SCORING SYSTEM:
Ocular reaction was scored using the following scale (adapted from Draize, according to US Consumer Product Safety Commission guide) :

- Corneal opacity (maximum possible 4):

0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacrous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible through the opacity

- Iris (maximum possible 2):

0 = Normal
1 = Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperhemia, or injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, hemorrhage, gross destruction (any or all of these)

- Conjunctivae:

Redness (refers to palpebral and bulbar conjunctivae, cornea and iris, maximum possible 3):
0 = Blood vessels normal
1 = Some blood vessels definitely hyperhemic (injected)
2 = Diffuse, crimson color, individual vessels not easily discernible
3 = Diffuse beefy red

Chemosis (lids and/or nictitating membranes, maximum possible 4):
0 = No swelling
1 = Any swelling above normal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = Swelling with lids about half closed
4 = Swelling with lids more than half closed

Ocular irritation was evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.

TOOL USED TO ASSESS SCORE:
Fluorescein (one drop of 1% sodium fluorescein) was instilled following reading at 24 hours, and subsequently washed out with sterile saline, for detection of corneal epithelium abnormalities.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours of application
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: Not applicable
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
See table below
Other effects:
No other effects were observed.
Noticeably, negative results were obtained at fluorescein staining 24 hours after instillation of the test substance.

Any other information on results incl. tables

Animal number     1  2  3
Cornea: opacity 1 h   0  0  0
  24 h  0  0  0
  48 h  0  0  0
  72 h  0  0  0
Iris: iritis 1 h  0  0  0
  24 h  0  0  0
  48 h  0  0  0
  72 h  0  0  0
Conjunctivae: redness 1 h  1  2  1
  24 h  0  1  0
  48 h  0  0  0
  72 h  0  0  0
Conjunctivae: chemosis 1 h  0  0  0
  24 h  0  0  0
  48 h  0  0  0
  72 h  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Slight or moderate conjunctival redness was observed in all three animals 1 hour following instillation of 0.1 mL of test substance. This finding was fully reversible within 24 to 48 h of instillation. Therefore, the test item was considered as non irritant and not classified for eye irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.
Executive summary:

In a primary eye irritation study (RBM study No. 970074), 0.1 mL of Tristyrenated phenol/Distyrenated phenol (75/25 molar %) were instilled into the conjunctival sac of the right eye of three male New Zealand White rabbits (2- to 3-month old). A washout was performed using sterile saline 24 hours after instillation. Local changes of cornea, iris and conjunctivae were observed 1, 24, 48 and 72 h after instillation. Fluorescein examination was also performed 24 hours after instillation. Irritation was scored by the method of US Consumer Product Safety Commission, adapted from Draize, taking account of potential corneal opacity, iritis, and conjunctival redness or chemosis.

 

Slight or moderate conjunctival redness (grade 1 or 2) was observed in all three animals 1 hour following instillation of the test substance. Slight redness (grade 1) was still observed 24 hours after instillation in the most severely affected animal. Conjunctival redness was fully reversible within 24 to 48 hours of instillation. Therefore, the test item was considered as non irritant to the eye.

 

In this study, Tristyrenated phenol/Distyrenated phenol (75/25 molar %) is not an eye irritant based on the low severity and complete reversibility of local changes following conjunctival instillation of 0.1 mL.

TSP/DSP is not classified for eye irritation according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS.