Alcohols, C20-22, reaction products with phosphorus oxide (P2O5)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-04-03 to 2000-06-23

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

- form: solid
- storage: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

3 female albinos rabbits, numerated A3213 to A3215 of new-zealand strain, originating from the Elevage de Gérome (Quartier Labaste – 40260 Linxe) were kept during a 7-day acclimatisation period. During the test, the animals weighted between 2.11kg and 2.41kg.
The animals were kept in individual boxes installed in conventional air conditioned animal husbanding; the environmental conditions were:
- temperature : between 19°C and 22°C
- relative humidity : between 39% and 54%

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g/animal

Duration of treatment / exposure:

4 hours

Observation period:

1 hour, 24, 48 and 72 hours after patch removal

Number of animals:

3

Details on study design:

- 3 rabbits, each animal was its own contol
- topic application for 4 hours under occlusive patch on the right flank for the test produt and on the left flank for the vehicle (distilled water)
- skin reactions (erythema and oedema) were scored 1 hour, 24, 48 and 72 hours after removal of the patch

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

24 hours after removal of the patch: 0/3 animals with skin reaction
48 hours after removal of the patch: 0/3 animals with skin reaction
72 hours after removal of the patch: 0/3 animals with skin reaction
Total sum of registerd scores = 0
Primary skin irritation (PSi) =0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained, in these experimental conditions, enabled to conclude that the test product, according to the scales of interpretation retained :
- is non irritant to skin (PSi =0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,
- and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548 and 93/21.

Executive summary:

The test product was applied, as supplied, at the dose of 0.5g, under semi-occlusive dressing during 4 hours on an undamaged skin area of 3 rabbits, according to an experimental protocol established from the O.E.C.D. guideline (n° 404 dated July.17th,1992) and the method B.4 of the E.E.C. directive n° 92/69 dated December 29th,1992. No cutaneous reactions (erythema and oedema) were observed in any animal whatever the examination time. The results obtained, in these experimental conditions, enabled to conclude that the test product, according to the scales of interpretation retained :

- is non irritant to skin (PSi = 0) according to the classification established in the Journal Officiel de la République Française dated February 21st, 1982,

- and, must not be classified, according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548 and 93/21.