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Diss Factsheets

Administrative data

Description of key information

Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene were tested in albino rabbits according to OECD Guidelines 404/405, under GLP conditions. Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene are considered not irritating for eyes and slightly irritating for the skin.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
4 - 18 November, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed according OECD Guideline 404 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not controlled.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hare Marland
- Age at study initiation: 18 weeks
- Weight at study initiation: 2.554 - 3.446 kg
- Housing: individually in steenless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -21
- Humidity (%): 40 - 70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg/site
Duration of treatment / exposure:
3, 60 minutes, 4 hours
Observation period:
15 days
Number of animals:
3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: elastic bandage and non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with water
- Time after start of exposure: at end of exposure time

SCORING SYSTEM: scoring system of Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 3 min. exposure
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 3 min exposure
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 60 min exposure
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 60 min exposure
Score:
0.16
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: concerns 1/6 animals, score 1, only at t=48 hours
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hour
Score:
0.2
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Dermal irritation:
Exposure 3 minutes: no erythema, no edema
Exposure 60 minutes: very slight erythema, no edema
Exposure 4 hours: very slight erythema, no edema

Corrosivity:
No necrosis observed.
Other effects:
none

none

Interpretation of results:
slightly irritating
Remarks:
Migrated information non-corrosive Criteria used for interpretation of results: OECD GHS
Conclusions:
A study in 3 male and 3 female rabbits revealed that Wingstay L was slightly irritant after 4-hour exposure. The test substance was considered non-corrosive. The study was performed according to the general guidelines for acute dermal irritation/corrosion under GLP conditions.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15-12-1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed according OECD Guideline 405 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not controlled.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harald Schriever, Neuendamm 88, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually in steenless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 -20
- Humidity (%): 50 - 85
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
other: other eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye
Duration of treatment / exposure:
not rinsed
Observation period (in vivo):
1, 24, 48, 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: According to Draize

TOOL USED TO ASSESS SCORE: fluorescein + UV-light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0.25
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 24, 48, 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
see above table
Other effects:
none

none

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A study in 3 rabbits revealed that Lowinox R 22CP46 was not irritanting for the eye. The study was performed according to the general guidelines for acute eye irritation/corrosion under GLP conditions.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The data of two dermal irritation/corrosion studies in albino rabbits meet the requirements of the current guidelines, although the identity and quality control of the tested substances is not demonstrated. Assuming that 100% pure testing substances were used, phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene were not or slightly irritating on rabbit skin.

In addition, the data of one eye irritation/corrosion study in albino rabbits meet the requirements of the current guidelines, although the identity and quality control of the tested substances is not demonstrated. Assuming that 100% pure testing substances were used, phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene were not irritating for rabbit eyes.

Justification for selection of skin irritation / corrosion endpoint:

Klimisch 1 study

Justification for selection of eye irritation endpoint:

Klimisch 1 study

Effects on skin irritation/corrosion: slightly irritating

Justification for classification or non-classification

According to the results of the skin and eye irritation studies, the substance does not need to be classified according to the CLP Regulation.