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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
1,1'-[methylenebis(oxy)]dibutane
EC Number:
219-909-0
EC Name:
1,1'-[methylenebis(oxy)]dibutane
Cas Number:
2568-90-3
Molecular formula:
C9H20O2
IUPAC Name:
1,1'-[methylenebis(oxy)]dibutane
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 or test system 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