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Diss Factsheets

Administrative data

Description of key information

Skin irrtitation: All animals revealed very slight oedema and erythema (score 1) after 1 h. Only one very slight

erythema remained in 1 animal after 24 h, and scoring at all further time-points was negative for all parameters.

Eye irritation:

The tested material induced significant damage to the rabbit eye and is considered to be irritating

to the eye.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
other: SCCS opinion/ 1439/11
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Not specified
Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
Guideline: OECD 404 (1992)
Species: New Zealand white rabbits
Group size: 3 females
Test substance: DA 060492 (Indigofera tinctoria leaf powder)
Batch: type 210741, 03.02.94.
Purity: /
Dose levels: approx. 80 mg/cm²
Route: dermal
Exposure: 4 h
GLP: in compliance
Date: 1994

Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Details on study design:
A cellulose patch with 0.5 g of DA 060492 was spread over approx. 6 cm² and fixed with a
non-irritating tape. Animals were examined for erythema/eschar and oedema as well as for
local and systemic signs: 1, 24, 48 and 72 h after patch removal.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
< 1
Max. score:
1
Reversibility:
not specified
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
All animals revealed very slight oedema and erythema (score 1) after 1 h. Scoring at all further time-points was negative for all parameters. Indigo powder is considered as non-irritating to the skin in this test.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
other: SCCS Opinion /1439/11
Adequacy of study:
key study
Study period:
1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
not specified
Principles of method if other than guideline:
DA 060492 was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second. The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp. The left eye served as the control.
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
not specified
Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
Group size: 3 females
Test substance: DA 060492 (Indigofera tinctoria leaf powder)
Batch: type 210741, 03.02.94
Purity: /
Dose levels: 47, 73, 71 mg, applied to animals 1, 2, and 3 respectively
Duration of treatment / exposure:
The sample was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second.
Observation period (in vivo):
The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp.
Number of animals or in vitro replicates:
3
Details on study design:
DA 060492 was administered to the conjunctival sac of the right eye, and the eye was held closed for about 1 second. The animals were examined at: 1, 24, 48 and 72 h using an otoscope-lamp. The left eye served as the control.
Irritation parameter:
chemosis score
Basis:
animal: 1,2,3
Time point:
other: 1 h
Reversibility:
not fully reversible within:
Remarks on result:
other: not specified
Remarks:
quantitative score not available, qualitative results referenced
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 6 d
Reversibility:
not reversible
Remarks on result:
other: not specified
Remarks:
quantitative score not available, qualitative results referenced
Irritation parameter:
other: Redness
Basis:
animal: 1,2,3
Time point:
other: 1 h
Reversibility:
not fully reversible within:
Remarks on result:
other: Not specified
Remarks:
quantitative score not available, qualitative results referenced
Irritation parameter:
other: redness
Basis:
animal #1
Time point:
other: 6 d
Reversibility:
not reversible
Remarks on result:
other: Not specified
Remarks:
quantitative score not available, qualitative results referenced
Irritation parameter:
cornea opacity score
Basis:
animal: 1,2
Time point:
other: 6 d
Reversibility:
fully reversible
Remarks on result:
other: not specified
Remarks:
Qualitative results reported
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Redness and chemosis were observed in 3 animals each 1 h after exposure to Indigofera ticntoria leaf powder(DA 060492) .
No alterations of cornea and iris were observed at this time-point, but scoring at later timepoints revealed corneal opacity in 2 animals. Redness and chemosis remained for several hours, and aggravated occasionally. Additional scoring after 6 and 8 days revealed no corneal opacity, but conjunctival redness and chemosis remained for 6 days in one animal.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Skin irrtitation, not classified. All animals revealed very slight oedema and erythema (score 1) after 1 h. Scoring at all further time-points was negative for all parameters. Indigo powder is considered as non-irritating to the skin in this test.

Eye irritation: Classified 2.

Redness (score 1 and 2) and chemosis (score 2 and 4) were observed in 3 animals each 1 h after

exposure to indigo powder. No alterations of cornea and iris were observed at this time-point, but

scoring at later time-points revealed corneal opacity in 2 animals. Redness and chemosis

remained for several hours, and aggravated occasionally. Additional scoring after 6 and 8 days

revealed no lesions of skin, but conjunctival redness and chemosis remained for 6 days in one

animal.