Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1997/10/17-1998/03/02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Development Detergent Alcohol 23731-52. Equivalent to Alcohols, C16-17, monobranched, type 2

- Substance type:

- Physical state: Clear, colourless liquid.

- Analytical purity: Purity data are the responsibility of the sponsor

- Storage condition of test material: Stored under nitrogen in the original container at room temperature.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: Covance Research Products, Inc., Denver, PA

- Age at study initiation: Young adults.

- Weight at study initiation: 3686 - 3790g

- Housing: Individual suspended wire mesh cages.

- Diet: PMI Feeds, Inc. Certified Rabbit LabDiet 5322, at ca. 150 g per day during the study

- Water: Reverse osmosis treated municipal water (ad libitum)

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 66-67.6

- Humidity (%): 41.3-45.9%

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.5ml


Duration of treatment / exposure:
1h and 4 h
Observation period:
15 days
Number of animals:
3 females
Details on study design:
TEST SITE

- Area of exposure: The back

- coverage: 2.5x2.5cm

- Type of wrap if used: The dose was applied under a two-ply gauze patch secured in place with Micropore tape. The patches were overwrapped with a gauze binder and secured with Dermiform tape.


REMOVAL OF TEST SUBSTANCE

- Washing (if done): The test site was wiped with a disposable paper towel moistened with tepid tap water.

- Time after start of exposure: 1h or 4 hours.


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 23/48/72h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 12 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.9
Max. score:
2
Reversibility:
fully reversible within: 12 days
Irritant / corrosive response data:
There were no mortalities during this study. Slight to moderate erythema, very slight oedema and desquamation were noted on all three 4 hour exposure sites. There were no other dermal findings. Oedema completely subsided by day 4 or earlier for all animals. Erythema completely subsided by day 12 or earlier for two rabbits. Very slight erythema with desquamation persisted through day 15 (termination) for the remaining animal.
Other effects:
There were no remarkable changes or differences observed in body weights during the study.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Erythema

Edema

Max. score: 4

Max. score: 2

60 min

2/2/1

1/1/0 

24 h

 3/2/2

 2/2/1

48 h

 2/2/2

 1/1/0

72 h

 2/1/2

 1/0/0

Average 24h, 48h, 72h

 2.3/1.7/2.0

 1.3/1.0/0.3

Reversibility*)

 c

Average time (unit) for reversion

 12 days or less

12 days or less

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on EU criteria, the test material is not considered to be a skin irritant as determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.