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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: There are some restriction concerning the method and the documentation of the results. The study is however suficient for endpoint evaluation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
occlusive application of 1 mL; 72 h reading is missing; observation period 8 days
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Neodecanoyl chloride
EC Number:
254-875-0
EC Name:
Neodecanoyl chloride
Cas Number:
40292-82-8
Molecular formula:
C10H19ClO
IUPAC Name:
2,2-dimethyloctanoyl chloride
Details on test material:
Neodecanoyl chloride from BASF AG, substance No. 77/807. Degree of purity not reported

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler (breeder)
- Weight at study initiation: 2.78 -3.40 kg


ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
1 h/ 4 h
Observation period:
8 days
Number of animals:
2 per exposure period
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (mild detergent) concentrated and Lutrol:water 1:1

SCORING SYSTEM: OECD/Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
4 h exposure
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
other: hard and pergamentous necrosis observed, respectively; see table for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
4 h exposure
Time point:
other: 24 - 48 h
Score:
1.5
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1 h exposure
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d
Remarks on result:
other: at necropsy, leather-like necrosis was observed in 1/2 animals; scaling
Irritation parameter:
edema score
Basis:
mean
Remarks:
1 h exposure
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 d

Any other information on results incl. tables

Exposition:  1 h
Animal  Reading  Erythema Edema Comment
1 24 h 2 2  
2 24 h 2 2  
1 48 h 2 2  
2 48 h 2 2  
1 5 d 2 2 scaling
2 5 d 2 2 scaling
1 8 d 0 0 scaling; at necropsy, leather-like necrosis was reported
2 8 d 0 0 scaling
mean 24 - 48 h 2.00 2.00  
Exposition:  4 h
Animal  Reading  Erythema Edema Comment
1 24 h 2 1 erythema extending beyond the area of application
2 24 h 2 2 erythema extending beyond the area of application
1 48 h 2 1 erythema extending beyond the area of application
2 48 h 2 2 erythema extending beyond the area of application
1 5 d 4 2 hard necrosis, scaling
2 5 d 4 2 pergamentous necrosis, scaling
1 8 d 0 1 necrosis dropped, scar, scaling
2 8 d 4 2 necrosis eaten, scar, scaling
mean 24 - 48 h 2.00 1.50  

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information