Registration Dossier

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: Study performed prior to OECD guideline and GLP, but followed principles thereof. Since the test substance is a strong alkaline substance, study results can be regarded as valid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: CFR/USA Title 16, 1500.41
Deviations:
no
Principles of method if other than guideline:
Method: other: acc. to Draize Test
GLP compliance:
no
Remarks:
prior to GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material (as cited in study report): Triacetondiamin
- Substance type: colourless liquid with low viscosity
- Physical state: liquid
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: J. Scheele, Büdrich/Westfalen, Werl, Germany
- Housing: individually
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
Temperature: 21-23°C
climated rooms
light circle dark/light: 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml undiluted
Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100
- Type of wrap if used: gauze with non irritating tape. Additionally, the whole trunk was wrapped with an impermeable rubber blanket for 24 hours to avoid evaporation of volatile substance


REMOVAL OF TEST SUBSTANCE
- Washing : not reported
- Time after start of exposure: not reported


SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
> 8
Max. score:
8
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: irritation index could not be calculated, but in all animals (intact and abraded skin) black-coloured necrosis occurred
Irritant / corrosive response data:
Dry black-coloured necrosis was observed. No derivation of a primary irritation index was possible.

Any other information on results incl. tables

The extrapolation to 4-h exposure is limited: Based on current standards, the finding does not allow to conclusively assess whether reversible lesions or necrosis would result.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Remarks:
Migrated information
Conclusions:
Six rabbits exposed for 24 hours to 0.5 mL test substance under occlusive condition revealed black-colured necroses on the intact and abraded skin
were observed up to 72 hours after patch removal. Reversibilty of the necrosis cannot be judged because observation time was limited to 72 hours. Therefore, the substance is regarded to be corrosive.