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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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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
Study period:
from 22 to 24 Feb 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Citric acid
EC Number:
201-069-1
EC Name:
Citric acid
Cas Number:
77-92-9
Molecular formula:
C6H8O7
IUPAC Name:
citric acid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped: abraded and non-abraded
Vehicle:
water
Controls:
not required
Duration of treatment / exposure:
4 h
Observation period:
observed at 0, 20 and 44 h following 4-h exposure
Number of animals:
3
Details on study design:
Tested as 30% aqueous solution on intact and abraded skin under an occlusive covering. Examined at 0, 20 and 44 h following 4 -h exposure;. Current guidelines recommend
examination at 1, 24, 48 and 72 h, or until resolution of effects.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
(of all 3 animals)
Time point:
other: 0, 20, 44 h following 4-h exposure
Score:
0.8
Max. score:
8
Reversibility:
other: not fully reversible within: 44 h
Remarks on result:
probability of mild irritation
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
(of all 3 animals)
Time point:
other: 0, 20, 44 h following 4-h exposure
Score:
0
Max. score:
8
Remarks on result:
no indication of irritation
Other effects:
-

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.

Score at time point / Reversibility   Erythema/eschar  Edema
 Intact skin  Max. score: 4  Max. score: 4
 0 h   0/0/0   0/0/0
 20 h   0/0/0   0/0/0
 44 h   0/0/0   0/0/0
 Average 0 h, 20 h, 44 h     0
 Abraded skin    
0 h   1/1/2  1/1/1
 20 h  1/1/1  0/0/1
 44 h  1/1/1  0/0/1
  Average 0 h, 20 h, 44 h     1.7
 Intact and abraded skin: average 0, 20, 44 h     0.8

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A study conducted largely in accordance with OECD 404, but without GLP and using an occlusive dressing, found citric acid to be non-irritant to the intact skin of rabbits. The PII score of 0.8/8, reflecting effects in abraded skin, was said to indicate a material that would be classified as non-irritant. Current EC criteria would concur with this finding.