Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

From a skin irritation study in rabbits it followed that the substance is corrosive to skin and from an eye irritation study in rabbits that the substance causes serious eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 6, 1992 - December 23, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Thomae, Biberach (6 males)
- Age at study initiation: no data
- Weight at study initiation: 2.25 kg +/- 0.172
- Housing: Building F-3, Rabbits per steel wire cage: 1
- Diet (e.g. ad libitum):ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- degrees Celsius
- Humidity (%): 45-65%
- Air changes (per hr): 12-15 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: July 28, 1992 To: August 19, 1992
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
Amount(s) applied (volume or weight with unit): 0.5 mL
VEHICLE: Not applicable
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 6 cm2 (2x3 cm gauze patch)
- Type of wrap if used: wrapping of gauze which was secured and semioccluded by a wrapping of fixomull.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: After a 4-hour exposure period wrappings were removed and the substance was washed away with water

SCORING SYSTEM: According to the method of Draize
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2.66
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Reversibility of any observed effect: Changes not fully reversible within 14 days in all animals.
Other effects:
The skin reactions increased up to 24 hours. After about 10 days, the upper layers of the skin fell off and the skin underneath was visible. It showed a beat red, shiny surface, which was about to heal.

Macroscopic findings during necropsy:

Animal No.

Pathol. No.

Necropsy day

Macroscopic finding

1

150/92

14

Treated skin severely red (beat red)

2

151/92

14

Treated skin red and scabby

3

152/92

14

Treated skin red and scabby

4

153/92

14

Treated skin red and scabby (petechiae in the underneath subcutaneous tissue)

5

154/92

14

Treated skin red and scabby (petechiae in the underneath subcutaneous tissue)

6

155/92

14

Treated skin red, scabby and ruptured

Interpretation of results:
Category 1C (corrosive)
Conclusions:
Based on the results of an in vivo skin irritation test performed according to OECD guideline 404, NBDI is classified Corrosive to skin (Category 1C).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 6, 1992 - December 23, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
other: US EPA Pesticide Assessment Guidelines, Subdivision F, Part 81-4 (Draize-Scoring)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Vehicle:
unchanged (no vehicle)
Controls:
other: The control eye was the untreated right eye
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
6 males
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 4 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.66
Max. score:
2
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 17 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.66
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #6
Time point:
24/48 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: Score 72 hours unreadable in report
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
In animal #2, the cornea was slightly obscured one hour after instillation. The other animals' cornea reacted after 24 hours. 72 hours after instillation, the rabbits # 1,3,4 and 6 did not show any corneal involvement anymore. In animals #2 and 5 the irritation lasted longer. The irises in animals # 5 and 6 reacted with swelling and congestion between 24 hours and 72 hours, but there was still reaction to light. The conjunctivae were extremely reddened, the lids showed swellings more than half closed, and a discharge could be seen which moistened the lids and hair considerably around the eye. these conjunctival changes started one hour after the instillation, increased to the 24-hours evaluation and then decreased to the day-21 evaluation.
The untreated eyes of the animals were not affected.
Other effects:
The area around the treated eye was involved in the eye irritation in the way that the eye lids hardened and the surrounding hair fell off. Due to this hardening the animals had difficulties in opening their treated eyes. The surrounding area also became more or less bloody and crusty which turned to be scrabby.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of an in vivo eye irritation test, NBDI is classified for serious damage to eyes (cat. 1).
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 irritation

As the substance caused irreversible damage to the skin, the substance needs to be classified with the hazard "corrosive to skin" in accordance with the CLP Regulation. In one animal the skin was ruptured (harmonized classification and labelling (see Annex VI Table 3.1 of EC Regulation No 1272/2008; Catalogus number: 615 -029 -00 -X).

Eye irritation

As in 1 animal (animal #5), effects on the cornea and conjunctiva did not fully reversed within the observation period of 21 days, the substance needs to be classified with the hazard "irreversible effects on the eye" in accordance with the CLP Regulation (self-clasification)