Registration Dossier

Administrative data

Description of key information

The test substance, 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with fatty acids, C18-unsatd., dimers was evaluated for eye and skin irritating potential in O.E.C.D. test guideline 404 and 405 studies with GLP compliance.  

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 404 with GLP compliance.
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:
The animals were acquired from Kleintierfarm Madoerin AG CR 4414 Fuellinsdorf / Switzerland were 14-15 weeks old and weighed 2.4-2.6 Kg. The animals were maintained Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 0—7830 Emmendingen / FRG). The rabbits were allowed access to Pelleted standard Kliba 341, rabbit maintenance diet (°Kliba, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) and water ad libitum. The animal room was air-conditioned with 10—15 air changes per hour and hourly monitored environment with temperature 20+—3 degrees centigrade, relative humidity 40—70%, 12 hours
artificial fluorescent light/12 hours dark/light period. The animals were acclimated to laboratory conditions for four days before being placed on-study.


Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
3 min, 1 hr and 4 hr
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study. One rabbit was initially treated. Three suitable sites were selected on the back of the
rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: all time points
Score:
ca. 0
Reversibility:
fully reversible within: not irritating
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The Primary Irritation Index of 0 suggests that the test substance is "not irritanting" to the skin. The study data does not support Classification and Labeling as a skin irritant.
Executive summary:

The test substance, 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with fatty acids, C18-unsatd., dimers was evaluated for skin irritation potential in an O.E.C.D. Test Guideline no 404 study. The Primary Irritation Index of 0 observed in the suggests that the test substance is "not irritanting" to the skin. The study data does not support Classification and Labeling as a skin irritant.

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 405 with GLP compliance.
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:
Two New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.30 or 2.89 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan
Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.1 mL neat
Duration of treatment / exposure:
72 hr
Observation period (in vivo):
72 hr
Number of animals or in vitro replicates:
2
Details on study design:
The test substance (0.1 ml per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for approximately one second to prevent loss of the test substance. The right eye remained untreated and served as the reference control.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1hr-72 hr.
Score:
ca. 9
Max. score:
110
Reversibility:
fully reversible
Remarks:
72 hrs
Irritant / corrosive response data:
Two test animals had a Conjunctival score of 10 and 8 at the 1 hr observation period.
Interpretation of results:
slightly irritating
Remarks:
Migrated information
Conclusions:
The total scores of 9.0 suggests that the test substance is a "mild irritant" to the eye. However, the study data does not support Classification and Labeling as an eye irritant.
Executive summary:

The test substance, 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with fatty acids, C18-unsatd., dimers was accesed for eye irritation potential in an O.E.C.D. test guideline no. 405 study. The test substance was mildly irritating to the rabbit eye under the conditions of the study. However, the study data does not support Classification and Labeling as an eye irritant.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The test substance was not irritating to the rabbit eye or skin when tested by O.E.C.D. test guideline methods. The test item produced a maximum group mean score of 9.0 out of 110 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.


Effects on eye irritation: slightly irritating

Justification for classification or non-classification

The data from standard O.E.C.D. test guideline studies demonstrates that the test substance is not irritating. No Classification and Labeling for irritation is required.