Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
other: Unpublished RIFM report
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Annex V of EEC Directive 79/831
Principles of method if other than guideline:
A 4 hour, semi-occlusive patch test was conducted on three New Zealand white albino rabbits using a 0.5 ml or 0.5 g aliquot of undiluted test material which was placed evenly over a 2.5 cm square of surgical lint B.P. The lint square was then placed onto a 6 cm square area of clipped, intact dorsal skin. The lint patches were held in place by encircling the trunk of the animals with a length of 'Elastoplast' elastic adhesive bandage 10 cm wide. After a period of 4 hours the adhesive tapes were removed and the treated sites cleansed by gentle swabbing with cotton wool soaked in warm water. Reactions were assessed at 1, 24, 48, 72 and 168 hours after patch removal. Irritation was assessed and allocated a numerical value based on the following: Erythema and Eschar Formation - No erythema = 0; Very slight erythema (barely perceptible) = 1; Well-defined erythema = 2; Moderate to severe erythema = 3; Severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4. Oedema Formation - No oedema = 0; Very slight oedema (barely perceptible) = 1; Slight oedema (edges of area well-defined by definite raising) = 2; Moderate oedema (raised approximately 1 mm) = 3; Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4.


Species:
rabbit
Type of coverage:
occlusive
Preparation of test site:
clipped
Irritation / corrosion parameter:
other: average erythema score
Value:
ca. 1
Irritation / corrosion parameter:
other: average edema score
Value:
ca. 0.2
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Irritation parameter:
cornea opacity score
Value:
ca. 0
Irritation parameter:
other: Iris lesion
Value:
ca. 0
Irritation parameter:
other: Redness of conjunctiva
Value:
ca. 0.6
Irritation parameter:
other: Oedema of conjunctiva
Value:
ca. 0.3
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification