Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
25. Sep 1968 - 03. Oct 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented report which meet sbasic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Principles of method if other than guideline:
Method: BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Butylal; Formaldehyddibutylacetal
- Physical state: liquid
- Analytical purity: 98-99 %

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.56 kg and 2.98 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated skin of the same animals served as control
Duration of treatment / exposure:
1, 5, 15 min and 20 h
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
; 1 min and 5 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
; 15 min h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.75
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
erythema score
Remarks:
; 20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2.75
Max. score:
4
Reversibility:
fully reversible within: 8 days in 1/2 animals
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
; 1 min and 5 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
0
Max. score:
4
Reversibility:
other: after 8 days scaling was noted
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
; 15 min exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
1.5
Max. score:
4
Reversibility:
other: after 8 days scaling was noted
Remarks on result:
other: 72 h reading is missing
Irritation parameter:
edema score
Remarks:
; 20 h exposure
Basis:
mean
Time point:
other: 24 h - 48 h - 72 h
Score:
2
Max. score:
4
Reversibility:
other: after 8 days scaling was noted
Remarks on result:
other: 72 h reading is missing

Any other information on results incl. tables

Mean erythema scores after (animal1/animal 2).

 Exposure time  same day  24 h  48 h  72 h  8 days            
 1 min 1/2 3/3 2/2 -/- 0/0            
 5 min 2/2 3/3 2/2 -/- 0/0            
 15 min 2/2 3/3 3/2 -/- 0/2            
 20 h  -/-  3/3  3/2  -/-  0/2              

Mean edema score after (animal1/animal 2).

 Exposure time  same day  24 h  48 h  72 h  8 days            
 1 min 0/0 0/0 0/0 -/- 0/0            
 5 min 0/0 0/0 0/0 -/- 0/0            
 15 min 0/0 2/2 2/0 -/- 0/0            
 20 h  -/-  2/2  2/2  -/-  0/0              

The original BASF grading was converted into the numerical grading according the OECD Draize system.

The application of the test substance for 1, 5, 15 min and 20 h let after 24 h to irritations, predominatly expressed by wide spanning, moderate erythema (1, 5, 15 min and 20 h exposure) and slight edema (15 min and 20 h exposure).

At the end of the observation period of 8 days slight erythema (15 min and 20 h exposure) was observed. Furthermore mild scaling was observed in one animal 8 days after 1, 5 and 15 min exposure time and in both animals 8 days after 20h exposure time.

Applicant's summary and conclusion