Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
75782-87-5
EC Number:
616-261-4
Cas Number:
75782-87-5
IUPAC Name:
75782-87-5
Details on test material:
Tradename Alchem 145

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Source: Padre Antonio Breeding Centre, Mariano Comense, Italy
- Weight at study initiation: 2-3 kg

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hour(s)
Observation period:
7 days (Examination time points: 1, 24, 48 and 72 hours, 5 and 7 days)
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6x6cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water or appropriate solvent.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.4
Max. score:
0.7
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.4
Max. score:
0.7
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
- Erythema: Individual 24+48+72 hour scores 5 rabbits gave a score of  0.3, the remaining rabbit gave a score of 0.7 
(group mean 24+48 +72 hour  score 0.4)
- Oedema: Individual 24+48+72 hour scores 5 rabbits gave a scores of 0.3,  the remaining rabbit gave a score of 0.7 
(group mean 24+48 +72 hour score  0.4)
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Following a 4 hour occlusive exposure Alchem 145 was not irritating to rabbit skin when assessed by either EU or GHS criteria. All scores <1.5.