Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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: Published peer reviewed study

Data source

Reference
Reference Type:
secondary source
Title:
Acute toxicity and skin corrosion data for some organic and inorganic compounds and aqueous solutions
Author:
Vernot, E.H. MacEwen, J.D. Haun, C.C. Kinkead, E.R.
Year:
1977
Bibliographic source:
Toxicology and Applied Pharmacology 42: 417-423

Materials and methods

Test guidelineopen allclose all
Qualifier:
no guideline followed
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The study was conducted prior to development of the OECD guidelines, however the methods are broadly comparable to OECD 404.
GLP compliance:
not specified
Remarks:
: older published study, pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonia, anhydrous
EC Number:
231-635-3
EC Name:
Ammonia, anhydrous
Cas Number:
7664-41-7
Molecular formula:
H3N
IUPAC Name:
ammonia
Details on test material:
Aqueous ammonia (NH4OH); anhydrous ammonia in solution

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Albino New Zealand White rabbits, weighing 3-4 kg, maintained on Purina Rabbit Chow.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
10% aqueous ammonia (NH4OH); 12% aqueous ammonia (NH4OH), calculated as percentage by weight in aqueous solution. 0.5 ml was applied to the skin.
Duration of treatment / exposure:
4 hours
Observation period:
The skin reactions were observed once at patch removal
Number of animals:
3 female rabbits per dose, with two replicates per rabbit at each concentration
Details on study design:
All hair was clipped from the backs and flanks of the rabbits, 24 hours prior to application. 0.5 ml test material was applied to the area of skin and covered by a 1 inch-square of surgical gauze, two single layers thick. The patches were held in place with strips of Elastoplast tape. The patches remained in place for 4 hours, during which time the rabbits were fitted with leather restraining collars. After the 4 hour exposure period, the patches were removed and the test areas were evaluated for visible tissue destruction. If severe skin damage was noted at two out of six sites, then the material was classified as corrosive.

Results and discussion

In vivo

Irritant / corrosive response data:
A positive corrosive response was recorded for the 12% solution.
Other effects:
No further information

Any other information on results incl. tables

12% aqueous ammonia was corrosive to the skin. 10% aqueous ammonia was not corrosive to the skin.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
12% aqueous ammonia was corrosive to the skin. 10% aqueous ammonia was not corrosive to the skin.
Executive summary:

The skin irritation/corrosion of different concentrations of aqueous ammonia was investigated in New Zealand White rabbits. The authors report that 12% aqueous ammonia was corrosive to the skin of rabbits following a 4 hour occlusive exposure on shaved skin. 10% aqueous ammonia was not corrosive to the skin of rabbits.