Phenol, 2-methoxy-, reaction products with 2,2-dimethyl-3-methylenebicyclo[2.2.1]heptane, hydrogenated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

(no data on starting date) 30-AUG 1976 (date of report)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted before GLP principles (1976). However, study performed according to basic scientific principles acceptable for assessment although some information is missing on test conditions and on tes substance composition.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: performed according to standard method

Deviations:

not applicable

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Santal synthétique
- Analytical purity: not specified
See confidential details on test material for more information

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data available
- Age at study initiation: no data available
- Weight at study initiation: no data available
- Housing: no data available
- Diet (e.g. ad libitum): no data available
- Water (e.g. ad libitum): no data available
- Acclimation period: no data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): no data available

IN-LIFE DATES: From: To: no data available

Test system

Type of coverage:

not specified

Preparation of test site:

other: intact skin and abraded skin

Vehicle:

other: vaseline oil

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Concentration: 100% (as such) and 30% (diluted product in vaseline oil)

VEHICLE
Vaseline oil. No other information available.

NEGATIVE CONTROL
No data available

POSITIVE CONTROL
No data available

Duration of treatment / exposure:

no data available

Observation period:

3 days

Number of animals:

6 for each concentration

Details on study design:

TEST SITE
- Area of exposure: no data available. The product has been applied on the intact and abraded skin.
- % coverage: no data available
- Type of wrap if used: no data available

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

OBSERVATION TIME POINTS
24 and 72 hours

SCORING SYSTEM:
- Method of calculation: no data available

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Reversibility:

not specified

Remarks on result:

other: Intact skin / product as such (concentration: 100%)

Remarks:

48h: not determined

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Remarks on result:

other: intact skin / product as such (concentration: 100%)

Remarks:

48h: not determined

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.25

Reversibility:

not specified

Remarks on result:

other: abraded skin / product as such (concentration: 100%)

Remarks:

48h not determined

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible

Remarks on result:

other: abraded skin / product as such (concentration: 100%)

Remarks:

48h not determined

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

1.29

Max. score:

8

Reversibility:

not specified

Remarks on result:

other: 48h not determined

Irritant / corrosive response data:

Based on this score, the substance is slightly irritating to rabbit's skin.

No detail is given to the concentration of 30%, since no signs of irritation were noted.

Any other information on results incl. tables

Table 1: local skin tolerance in rabbits - 100% concentration (product as such)

 

Observation after :	Rabbit N°	Intact skin		Abraded skin
		Erythema	Edema	Erythema	Edema
24 hours	1 2 3 4 5 6	1 1 0 1 2 1	0 0 0 0 0 0	2 2 2 2 2 2	2 1 1 1 2 1
72 hours	1 2 3 4 5 6	0 1 0 0 1 0	0 0 0 0 0 0	1 1 0 0 1 0	0 0 0 0 0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the Un GHS and CLP criteria, the substance is not classified for the skin irritation.

Executive summary:

Rhodiantal IBCH (100% (as such) and 30% (diluted product in vaseline oil) has been applied to the intact and abraded skin of six rabbits.

Period of observation: 24 and 72 hours. No more information is available.

Results: For the concentration of 100%, the mean scores (24 and 72h) were 0.66 for erythema and 0 for edema on the intact skin . Based on this score the substance is slightly irritating to rabbit’s skin.

According to the UN GHS and CLP criteria, the substance is not classified for the skin irritation.

For the concentration 30%, no signs of irritation were noted.