Registration Dossier

Administrative data

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: GLP compliant, OECD Guideline study performed without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes
Remarks:
US EPA TSCA GLPs (40 CFR, Part 792); OECD GLPs

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Dimethyl cyclohexyl bisphenol (DMBPC; CAS No. 2362-14-3)
- Synonyms: Dimethyl bisphenolcyclohexane; 4,4’-cyclohexylidene di-o-cresol; 1,1-Bis(4-hydroxy-3-ethyl)cyclohexane; Bis-OC-Z
- Appearance: fine white powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Details on test animals and environment: Two male and one female (nulliparous and non-pregnant) New Zealand White rabbits, at least 10 weeks of age, weighing 2.09 to 2.26 kg were obtained from the supplier. The animals were acclimated for at least five days and individually housed in suspended stainless-steel cages with hardwood chips for bedding. They were provided food and tap water ad libitum. Room temperature was 68 ± 5 °F and the relative humidity ranged between 30 - 70 %. Room lights were on a 12-hour light/dark cycle.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Approximately 0.5 gram of the test substance was applied to a small area of the skin (approximately 6 cm²).
Duration of treatment / exposure:
4 hour exposure period
Observation period:
Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs.
Number of animals:
3
Details on study design:
Approximately 24 hours prior to dosing, the application sites were prepared by clipping the skin of the trunk free of hair (not less than 10 % of the body surface was clear for the application of the test substance). Approximately 0.5 gram of the test substance was applied to a small area of the skin (approximately 6 cm²). The application site was covered with a gauze patch and secured with non-irritating tape. The test was conducted with 3 animals, each receiving one patch for an exposure period of 4 hours. Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs. Animals were weighed on Day 0 (prior to dose administration) and at the end of the observation period (Day 3). All animals were euthanised with an injectable barbiturate after body weight collection on Day 3 and discarded without further evaluation.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72
Score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No signs of erythema or edema were present at any of the test or control sites at any of the observation periods.
Other effects:
All animals gained weight over the course of the study. No overt signs of toxicity were evident in any of the animals during the course of the study.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, DMBPC is considered to be a non-irritant.
Executive summary:

The irritation potential of the test material was investigate din accordance with the standardised guidelines OECD 404 and EPA OPPTS 870.2500 under GLP conditions.

The shaved skin of 3New Zealand White rabbits was exposed to the test material in a semi-occlusive fashion for 4 hours. Approximately 0.5 gram of the test substance was applied to a small area of the skin (approximately 6 cm²). 

Test sites were observed for signs of erythema and oedema 1, 24, 48 and 72 hours after patch removal. Daily clinical observations included all toxicologic and pharmacologic signs. 

Animals were weighed on Day 0 (prior to dose administration) and at the end of the observation period (Day 3). All animals were euthanised with an injectable barbiturate after body weight collection on Day 3 and discarded without further evaluation.

No signs of erythema or oedema were present at any of the test or control sites at any of the observation periods.

All animals gained weight over the course of the study. No overt signs of toxicity were evident in any of the animals during the course of the study.

Under the conditions of this study, DMBPC is considered to be a non-irritant.